Your new company This is a growing pharmaceutical business with an expanding product portfolio, committed to maintaining high standards of quality, compliance, and patient safety. The organisation operates internationally, working closely with manufacturing partners, quality teams, and regulatory bodies across the UK, EU, and global markets. Your new role As Quality Manager, you will lead and develop the Quality Assurance function, taking full responsibility for a QA Operations team based in India. You will ensure alignment with UK/EU regulatory requirements and internal quality standards while driving continuous improvement across the Quality Management System (QMS).You will collaborate closely with Qualified Persons (QPs), manufacturing sites, corporate quality teams, and external partners. Your role will focus on maintaining compliance, supporting audit readiness, and delivering operational excellence across the business.Key responsibilities include managing QA operations, overseeing deviations, CAPA, change controls, and audits, ensuring effective complaint handling and quality trending, supporting regulatory inspections, and leading continuous improvement initiatives across the quality function. What you'll need to succeed Extensive experience (typically 8-12+ years) in Quality Assurance within the pharmaceutical industry Strong leadership experience, including managing India-based teams In-depth knowledge of UK and EU pharmaceutical regulations and GMP requirements Hands-on experience across QMS processes (deviations, CAPA, change control, audits) Experience supporting regulatory inspections and maintaining audit readiness Background working with CMOs, QC laboratories, and global supply chains Strong problem-solving and root cause analysis skills Excellent communication and stakeholder engagement skills High level of organisation, integrity, and ability to work to deadlines What you'll get in return Opportunity to lead a key function within a growing pharmaceutical business International exposure working with global teams and partners A strategic role with real influence on quality, compliance, and operational performance The chance to drive continuous improvement across a developing QMS What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
Jul 13, 2026
Full time
Your new company This is a growing pharmaceutical business with an expanding product portfolio, committed to maintaining high standards of quality, compliance, and patient safety. The organisation operates internationally, working closely with manufacturing partners, quality teams, and regulatory bodies across the UK, EU, and global markets. Your new role As Quality Manager, you will lead and develop the Quality Assurance function, taking full responsibility for a QA Operations team based in India. You will ensure alignment with UK/EU regulatory requirements and internal quality standards while driving continuous improvement across the Quality Management System (QMS).You will collaborate closely with Qualified Persons (QPs), manufacturing sites, corporate quality teams, and external partners. Your role will focus on maintaining compliance, supporting audit readiness, and delivering operational excellence across the business.Key responsibilities include managing QA operations, overseeing deviations, CAPA, change controls, and audits, ensuring effective complaint handling and quality trending, supporting regulatory inspections, and leading continuous improvement initiatives across the quality function. What you'll need to succeed Extensive experience (typically 8-12+ years) in Quality Assurance within the pharmaceutical industry Strong leadership experience, including managing India-based teams In-depth knowledge of UK and EU pharmaceutical regulations and GMP requirements Hands-on experience across QMS processes (deviations, CAPA, change control, audits) Experience supporting regulatory inspections and maintaining audit readiness Background working with CMOs, QC laboratories, and global supply chains Strong problem-solving and root cause analysis skills Excellent communication and stakeholder engagement skills High level of organisation, integrity, and ability to work to deadlines What you'll get in return Opportunity to lead a key function within a growing pharmaceutical business International exposure working with global teams and partners A strategic role with real influence on quality, compliance, and operational performance The chance to drive continuous improvement across a developing QMS What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
Your new company An established, research-driven generics pharmaceutical company with a strong presence across the UK and EU markets. The organisation offers a collaborative, team-oriented environment and is committed to delivering high-quality, affordable medicines while supporting employee development. Your new role As a Senior Regulatory Affairs Associate, you will support the lifecycle management of a diverse portfolio of generic medicinal products. You will be responsible for preparing and submitting regulatory dossiers (including MAAs, variations, and renewals) in line with MHRA and EMA requirements, as well as managing post-approval activities.You will liaise with regulatory authorities, respond to queries within agreed timelines, and ensure compliance of product labelling and documentation (SmPCs, PILs, artwork). The role also involves supporting regulatory strategy, tracking submission timelines, and monitoring evolving regulatory guidelines to assess business impact. What you'll need to succeed Degree in Life Sciences, Pharmacy, or a related field Proven Regulatory Affairs experience within the pharmaceutical industry (generics preferred) Strong knowledge of UK (MHRA) and EU regulatory frameworks Experience with CTD/eCTD submissions and lifecycle management Familiarity with variations and post-approval processes Excellent organisational and communication skills Ability to manage multiple projects in a fast-paced environment What you'll get in return Hybrid working (3 days onsite in London, 2 days remote) Opportunity to work within a collaborative and supportive team Exposure to a broad and varied generics portfolio across UK and EU markets Career development and ongoing training opportunities What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
Jul 13, 2026
Full time
Your new company An established, research-driven generics pharmaceutical company with a strong presence across the UK and EU markets. The organisation offers a collaborative, team-oriented environment and is committed to delivering high-quality, affordable medicines while supporting employee development. Your new role As a Senior Regulatory Affairs Associate, you will support the lifecycle management of a diverse portfolio of generic medicinal products. You will be responsible for preparing and submitting regulatory dossiers (including MAAs, variations, and renewals) in line with MHRA and EMA requirements, as well as managing post-approval activities.You will liaise with regulatory authorities, respond to queries within agreed timelines, and ensure compliance of product labelling and documentation (SmPCs, PILs, artwork). The role also involves supporting regulatory strategy, tracking submission timelines, and monitoring evolving regulatory guidelines to assess business impact. What you'll need to succeed Degree in Life Sciences, Pharmacy, or a related field Proven Regulatory Affairs experience within the pharmaceutical industry (generics preferred) Strong knowledge of UK (MHRA) and EU regulatory frameworks Experience with CTD/eCTD submissions and lifecycle management Familiarity with variations and post-approval processes Excellent organisational and communication skills Ability to manage multiple projects in a fast-paced environment What you'll get in return Hybrid working (3 days onsite in London, 2 days remote) Opportunity to work within a collaborative and supportive team Exposure to a broad and varied generics portfolio across UK and EU markets Career development and ongoing training opportunities What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
Your new company An established, research-driven generics pharmaceutical company with a strong presence across the UK and EU markets. The organisation offers a collaborative, team-oriented environment and is committed to delivering high-quality, affordable medicines while supporting employee development. Your new role As a Senior Regulatory Affairs Associate, you will support the lifecycle management of a diverse portfolio of generic medicinal products. You will be responsible for preparing and submitting regulatory dossiers (including MAAs, variations, and renewals) in line with MHRA and EMA requirements, as well as managing post-approval activities.You will liaise with regulatory authorities, respond to queries within agreed timelines, and ensure compliance of product labelling and documentation (SmPCs, PILs, artwork). The role also involves supporting regulatory strategy, tracking submission timelines, and monitoring evolving regulatory guidelines to assess business impact. What you'll need to succeed Degree in Life Sciences, Pharmacy, or a related field Proven Regulatory Affairs experience within the pharmaceutical industry (generics preferred) Strong knowledge of UK (MHRA) and EU regulatory frameworks Experience with CTD/eCTD submissions and lifecycle management Familiarity with variations and post-approval processes Excellent organisational and communication skills Ability to manage multiple projects in a fast-paced environment What you'll get in return Hybrid working (3 days onsite in London, 2 days remote) Opportunity to work within a collaborative and supportive team Exposure to a broad and varied generics portfolio across UK and EU markets Career development and ongoing training opportunities What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
Jul 13, 2026
Full time
Your new company An established, research-driven generics pharmaceutical company with a strong presence across the UK and EU markets. The organisation offers a collaborative, team-oriented environment and is committed to delivering high-quality, affordable medicines while supporting employee development. Your new role As a Senior Regulatory Affairs Associate, you will support the lifecycle management of a diverse portfolio of generic medicinal products. You will be responsible for preparing and submitting regulatory dossiers (including MAAs, variations, and renewals) in line with MHRA and EMA requirements, as well as managing post-approval activities.You will liaise with regulatory authorities, respond to queries within agreed timelines, and ensure compliance of product labelling and documentation (SmPCs, PILs, artwork). The role also involves supporting regulatory strategy, tracking submission timelines, and monitoring evolving regulatory guidelines to assess business impact. What you'll need to succeed Degree in Life Sciences, Pharmacy, or a related field Proven Regulatory Affairs experience within the pharmaceutical industry (generics preferred) Strong knowledge of UK (MHRA) and EU regulatory frameworks Experience with CTD/eCTD submissions and lifecycle management Familiarity with variations and post-approval processes Excellent organisational and communication skills Ability to manage multiple projects in a fast-paced environment What you'll get in return Hybrid working (3 days onsite in London, 2 days remote) Opportunity to work within a collaborative and supportive team Exposure to a broad and varied generics portfolio across UK and EU markets Career development and ongoing training opportunities What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
Your new company A leading CDMO delivering complex capital investment and strategic programme portfolios is seeking a Portfolio Risk Analyst to support the successful delivery of high-value projects and programmes. Operating within a regulated and technically complex environment, the business is focused on driving excellence in project governance, risk management, and investment delivery. Your new role As a Portfolio Risk Analyst, you will support the management of risks across a portfolio of strategic programmes and capital projects. You will identify, assess, analyse, and monitor risks that could impact cost, schedule, scope, safety, and delivery outcomes. Key responsibilities include: Maintaining portfolio-level risk profiles and risk registers Supporting quantitative cost and schedule risk analysis, contingency modelling, and uncertainty assessments Monitoring risk trends, emerging issues, and systemic portfolio risks Producing portfolio risk dashboards, reports, and key risk indicators Supporting governance reviews, investment decision-making processes, and business case assurance activities Working closely with project managers, finance, engineering, commercial teams, and external stakeholders Facilitating risk workshops and providing challenge to project assumptions and mitigation plans Driving continuous improvement in risk methodologies, analytics, reporting, and data quality What you'll need to succeed To be successful in this role, you will have: Strong understanding of risk management within project, programme, or capital investment environments Experience of cost and schedule risk analysis, contingency management, and uncertainty modelling Excellent communication skills with the ability to present complex information to a range of stakeholders The confidence to challenge assumptions and influence decision-making at multiple levels Experience within risk management, project controls, portfolio analysis, or capital project delivery Desirable experience includes: Experience working in capital-intensive or regulated industries Professional qualifications such as APM, PMI, IRM, or similar Knowledge of regulated manufacturing or engineering environments Experience supporting major CAPEX programmes What you'll get in return Opportunity to work on a diverse portfolio of strategic and high-value investment programmes Exposure to senior stakeholders and key business decision-making processes A collaborative and forward-thinking working environment Professional development and career progression opportunities Competitive salary and benefits package What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
Jul 10, 2026
Full time
Your new company A leading CDMO delivering complex capital investment and strategic programme portfolios is seeking a Portfolio Risk Analyst to support the successful delivery of high-value projects and programmes. Operating within a regulated and technically complex environment, the business is focused on driving excellence in project governance, risk management, and investment delivery. Your new role As a Portfolio Risk Analyst, you will support the management of risks across a portfolio of strategic programmes and capital projects. You will identify, assess, analyse, and monitor risks that could impact cost, schedule, scope, safety, and delivery outcomes. Key responsibilities include: Maintaining portfolio-level risk profiles and risk registers Supporting quantitative cost and schedule risk analysis, contingency modelling, and uncertainty assessments Monitoring risk trends, emerging issues, and systemic portfolio risks Producing portfolio risk dashboards, reports, and key risk indicators Supporting governance reviews, investment decision-making processes, and business case assurance activities Working closely with project managers, finance, engineering, commercial teams, and external stakeholders Facilitating risk workshops and providing challenge to project assumptions and mitigation plans Driving continuous improvement in risk methodologies, analytics, reporting, and data quality What you'll need to succeed To be successful in this role, you will have: Strong understanding of risk management within project, programme, or capital investment environments Experience of cost and schedule risk analysis, contingency management, and uncertainty modelling Excellent communication skills with the ability to present complex information to a range of stakeholders The confidence to challenge assumptions and influence decision-making at multiple levels Experience within risk management, project controls, portfolio analysis, or capital project delivery Desirable experience includes: Experience working in capital-intensive or regulated industries Professional qualifications such as APM, PMI, IRM, or similar Knowledge of regulated manufacturing or engineering environments Experience supporting major CAPEX programmes What you'll get in return Opportunity to work on a diverse portfolio of strategic and high-value investment programmes Exposure to senior stakeholders and key business decision-making processes A collaborative and forward-thinking working environment Professional development and career progression opportunities Competitive salary and benefits package What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
Your new company You'll be joining a global biopharmaceutical organisation supporting scientific information, intelligence, and data-driven decision-making across research and development as part of a highly experienced team with plenty of learning and training opportunities. The company has a highly collaborative environment where data science, AI, and scientific expertise are combined to generate insights from biomedical information sources. Your new role You'll be part of the company's R&D department, working as an Early Career / Junior Information Scientist to support the development of computational approaches for analysing scientific content and external data sources. This will be used to optimise the company's drug discovery and development plans across multiple disease areas. This is initially a 12-month contract that may extend and requires several days per week on site (likely 2-3 days per week home/remote working). Key responsibilities include: Developing and supporting automated workflows for scientific data analysis Applying data science and analytical techniques to identify trends and generate insights from biomedical / pharmaceutical data Building and maintaining content analytics pipelines Using AI, NLP, and text-mining approaches to analyse biomedical literature and scientific datasets Supporting the extraction, organisation, and interpretation of scientific information Collaborating with cross-functional stakeholders across research and development Contributing to data governance and responsible AI initiatives Supporting scientific information and intelligence activities through data-driven approaches All candidates MUST hold the full right to work for the entire length of the contract (likely at least September 2027) as no sponsorship is available. Candidates without this cannot be considered. What you'll need to succeed A strong candidate will combine scientific understanding with an interest in coding, analytics, and emerging AI technologies and should also have: A BSc / MSc (or equivalent experience) in Life Sciences, Data Science, Bioinformatics, Computational Biology, Computer Science, or a related field Good programming skills (e.g. Python, R, or similar) Strong analytical and problem-solving abilities An interest in data science, content analytics, and scientific information management - ideally with demonstrable work experience in this field The ability to work effectively with both scientific and technical stakeholders Strong communication and organisational skills as regular interaction with a range of stakeholders is a core part of the job Experience with NLP, machine learning, scientific datasets, or biomedical literature is a significant advantage - preferably gained from working in a pharmaceutical, biotech diagnostics, CRO or consultancy company supporting drug discovery / development projects Familiarity with metadata, ontologies, knowledge graphs, or information retrieval concepts is beneficial Full right to work in the UK What you'll get in return You'll get the chance to build your career within a fast-paced and highly innovative pharmaceutical company and make a real impact on some of their early drug discovery programmes. You'll also have flexible working, supportive colleagues and a good daily rate. What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.
Jul 10, 2026
Contractor
Your new company You'll be joining a global biopharmaceutical organisation supporting scientific information, intelligence, and data-driven decision-making across research and development as part of a highly experienced team with plenty of learning and training opportunities. The company has a highly collaborative environment where data science, AI, and scientific expertise are combined to generate insights from biomedical information sources. Your new role You'll be part of the company's R&D department, working as an Early Career / Junior Information Scientist to support the development of computational approaches for analysing scientific content and external data sources. This will be used to optimise the company's drug discovery and development plans across multiple disease areas. This is initially a 12-month contract that may extend and requires several days per week on site (likely 2-3 days per week home/remote working). Key responsibilities include: Developing and supporting automated workflows for scientific data analysis Applying data science and analytical techniques to identify trends and generate insights from biomedical / pharmaceutical data Building and maintaining content analytics pipelines Using AI, NLP, and text-mining approaches to analyse biomedical literature and scientific datasets Supporting the extraction, organisation, and interpretation of scientific information Collaborating with cross-functional stakeholders across research and development Contributing to data governance and responsible AI initiatives Supporting scientific information and intelligence activities through data-driven approaches All candidates MUST hold the full right to work for the entire length of the contract (likely at least September 2027) as no sponsorship is available. Candidates without this cannot be considered. What you'll need to succeed A strong candidate will combine scientific understanding with an interest in coding, analytics, and emerging AI technologies and should also have: A BSc / MSc (or equivalent experience) in Life Sciences, Data Science, Bioinformatics, Computational Biology, Computer Science, or a related field Good programming skills (e.g. Python, R, or similar) Strong analytical and problem-solving abilities An interest in data science, content analytics, and scientific information management - ideally with demonstrable work experience in this field The ability to work effectively with both scientific and technical stakeholders Strong communication and organisational skills as regular interaction with a range of stakeholders is a core part of the job Experience with NLP, machine learning, scientific datasets, or biomedical literature is a significant advantage - preferably gained from working in a pharmaceutical, biotech diagnostics, CRO or consultancy company supporting drug discovery / development projects Familiarity with metadata, ontologies, knowledge graphs, or information retrieval concepts is beneficial Full right to work in the UK What you'll get in return You'll get the chance to build your career within a fast-paced and highly innovative pharmaceutical company and make a real impact on some of their early drug discovery programmes. You'll also have flexible working, supportive colleagues and a good daily rate. What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.
About the Company A global biotech organisation with a strong pipeline of development and commercial products across multiple therapeutic areas is looking for a 12-month reg manager to join the team with scope to extend. Fully remote but you must be based in the UK. You will be responsible for supporting at least 3 projects, which could be in development or marked products. Responsibilities Manage CTA, MAA and post-approval regulatory submissions across Europe. Support regulatory strategy for development and marketed products. Provide regulatory guidance to cross-functional project teams. Support interactions with health authorities, including scientific advice and accelerated pathways. Contribute to labelling activities and life cycle management. Monitor regulatory changes and assess business impact. Conduct regulatory intelligence to support product development and submission planning. Requirements 5+ years Regulatory Affairs experience within pharma or biotech. Strong knowledge of EU CTR and MAA procedures. Understanding of drug development and LCM lifecycle management. Excellent communication and stakeholder management skills. Please apply now or reach out to hear more details.
Jul 10, 2026
Contractor
About the Company A global biotech organisation with a strong pipeline of development and commercial products across multiple therapeutic areas is looking for a 12-month reg manager to join the team with scope to extend. Fully remote but you must be based in the UK. You will be responsible for supporting at least 3 projects, which could be in development or marked products. Responsibilities Manage CTA, MAA and post-approval regulatory submissions across Europe. Support regulatory strategy for development and marketed products. Provide regulatory guidance to cross-functional project teams. Support interactions with health authorities, including scientific advice and accelerated pathways. Contribute to labelling activities and life cycle management. Monitor regulatory changes and assess business impact. Conduct regulatory intelligence to support product development and submission planning. Requirements 5+ years Regulatory Affairs experience within pharma or biotech. Strong knowledge of EU CTR and MAA procedures. Understanding of drug development and LCM lifecycle management. Excellent communication and stakeholder management skills. Please apply now or reach out to hear more details.
Your new company Are you an experienced Senior Medical Writer looking for your next long-term contract opportunity? I am currently partnering with a leading global pharmaceutical organisation seeking a Senior Medical Writer to join their clinical and regulatory writing team on an initial 12-month contract. This role sits within a high-performing global team and will suit a writer who is confident leading the development of complex regulatory and safety documentation whilst collaborating with cross-functional stakeholders across Clinical Development, Pharmacovigilance, Regulatory Affairs, Biostatistics and Medical Affairs. Your new role Lead the preparation, review and delivery of high-quality clinical and regulatory documents. Author and coordinate clinical study protocols and protocol amendments. Develop Pharmacovigilance and aggregate safety reports including: DSURs (Development Safety Update Reports) PBRERs (Periodic Benefit-Risk Evaluation Reports) Prepare clinical study reports, investigator brochures and other regulatory submissions as required. Support documentation associated with medical devices and combination products, ensuring compliance with relevant regulatory requirements. Collaborate with subject-matter experts to ensure scientific accuracy, consistency and timely delivery of documents. Drive document strategy, standards and quality across multiple development programmes. Ensure all documents meet global regulatory guidelines and company standards. What you'll need to succeed Significant experience working as a Medical Writer within the pharmaceutical, biotechnology, CRO or medical device sector. Demonstrable experience authoring clinical study protocols. Strong experience writing DSURs and PBRERs. Medical device and/or combination product documentation experience. Excellent understanding of regulatory requirements and industry guidelines, especially GVP Experience managing multiple deliverables across complex development programmes. Strong stakeholder management and communication skills. Degree qualified in a life sciences discipline (advanced degree advantageous). What you need to do now If you are a Senior Medical Writer with strong protocol, DSUR, PBRER and medical device experience and are looking for a long-term contract with a highly respected pharmaceutical company, I'd be delighted to discuss the opportunity with you. Click 'apply now' to forward an up-to-date copy of your CV, or call Roberta Atkins on (phone number removed) Before you apply for this position, it is vital that you are in possession of a UK passport or relevant visa to work without restrictions in the UK and must be based in the UK.
Jul 10, 2026
Contractor
Your new company Are you an experienced Senior Medical Writer looking for your next long-term contract opportunity? I am currently partnering with a leading global pharmaceutical organisation seeking a Senior Medical Writer to join their clinical and regulatory writing team on an initial 12-month contract. This role sits within a high-performing global team and will suit a writer who is confident leading the development of complex regulatory and safety documentation whilst collaborating with cross-functional stakeholders across Clinical Development, Pharmacovigilance, Regulatory Affairs, Biostatistics and Medical Affairs. Your new role Lead the preparation, review and delivery of high-quality clinical and regulatory documents. Author and coordinate clinical study protocols and protocol amendments. Develop Pharmacovigilance and aggregate safety reports including: DSURs (Development Safety Update Reports) PBRERs (Periodic Benefit-Risk Evaluation Reports) Prepare clinical study reports, investigator brochures and other regulatory submissions as required. Support documentation associated with medical devices and combination products, ensuring compliance with relevant regulatory requirements. Collaborate with subject-matter experts to ensure scientific accuracy, consistency and timely delivery of documents. Drive document strategy, standards and quality across multiple development programmes. Ensure all documents meet global regulatory guidelines and company standards. What you'll need to succeed Significant experience working as a Medical Writer within the pharmaceutical, biotechnology, CRO or medical device sector. Demonstrable experience authoring clinical study protocols. Strong experience writing DSURs and PBRERs. Medical device and/or combination product documentation experience. Excellent understanding of regulatory requirements and industry guidelines, especially GVP Experience managing multiple deliverables across complex development programmes. Strong stakeholder management and communication skills. Degree qualified in a life sciences discipline (advanced degree advantageous). What you need to do now If you are a Senior Medical Writer with strong protocol, DSUR, PBRER and medical device experience and are looking for a long-term contract with a highly respected pharmaceutical company, I'd be delighted to discuss the opportunity with you. Click 'apply now' to forward an up-to-date copy of your CV, or call Roberta Atkins on (phone number removed) Before you apply for this position, it is vital that you are in possession of a UK passport or relevant visa to work without restrictions in the UK and must be based in the UK.
Your new company A leading pharmaceutical manufacturing organisation is seeking an experienced CQV / Validation Engineer to support a programme of new asset introduction and qualification activities within a GMP regulated environment. Working alongside Engineering, Quality, Manufacturing and Project teams, you'll play a key role in ensuring critical equipment, facilities and utilities are introduced and maintained in a validated state. Your new role As the Validation Engineer, you will be responsible for delivering qualification and validation activities across laboratory and manufacturing systems. Key responsibilities will include: Authoring, reviewing and executing validation documentation including Validation Plans, Risk Assessments, IQ, OQ and PQ protocols and Validation Summary Reports. Supporting new equipment introduction projects from planning through to GMP release. Executing qualification activities for manufacturing and laboratory equipment. Performing thermal mapping activities on controlled temperature units (CTUs), including fridges, freezers, incubators and other GMP systems. Supporting qualification activities for equipment such as lyophilisers, sterilisers and associated utilities. Conducting pre-calibration and post-calibration activities. Managing deviations, investigations, CAPAs and change controls. Analysing qualification data and producing technical reports. Working closely with cross-functional stakeholders to deliver project milestones. What you'll need to succeed Proven experience within pharmaceutical, biotechnology or life sciences manufacturing environments. Strong background in equipment qualification and validation. Experience authoring and executing IQ, OQ and PQ protocols. Thermal mapping experience across controlled temperature units. Knowledge of GMP, EU GMP and validation life cycle requirements. Experience managing deviations, investigations and CAPAs. Ability to generate and review validation documentation independently. Excellent communication, technical writing and organisational skills. Desirable experience: New asset introduction projects. Lyophiliser qualification. Sterilisation validation. Utilities qualification (HVAC, WFI, Purified Water, Clean Utilities). Sterile manufacturing or aseptic processing environments. Must have Full Right to Work in the UK for duration of contract. No Sponsorship provided. What you'll get in return Long-term contract opportunity. Outside IR35 engagement. Competitive day rate. Opportunity to work on high-profile qualification and validation projects within a GMP manufacturing environment. Collaborative project team and exposure to significant new asset introduction activities. What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
Jul 08, 2026
Contractor
Your new company A leading pharmaceutical manufacturing organisation is seeking an experienced CQV / Validation Engineer to support a programme of new asset introduction and qualification activities within a GMP regulated environment. Working alongside Engineering, Quality, Manufacturing and Project teams, you'll play a key role in ensuring critical equipment, facilities and utilities are introduced and maintained in a validated state. Your new role As the Validation Engineer, you will be responsible for delivering qualification and validation activities across laboratory and manufacturing systems. Key responsibilities will include: Authoring, reviewing and executing validation documentation including Validation Plans, Risk Assessments, IQ, OQ and PQ protocols and Validation Summary Reports. Supporting new equipment introduction projects from planning through to GMP release. Executing qualification activities for manufacturing and laboratory equipment. Performing thermal mapping activities on controlled temperature units (CTUs), including fridges, freezers, incubators and other GMP systems. Supporting qualification activities for equipment such as lyophilisers, sterilisers and associated utilities. Conducting pre-calibration and post-calibration activities. Managing deviations, investigations, CAPAs and change controls. Analysing qualification data and producing technical reports. Working closely with cross-functional stakeholders to deliver project milestones. What you'll need to succeed Proven experience within pharmaceutical, biotechnology or life sciences manufacturing environments. Strong background in equipment qualification and validation. Experience authoring and executing IQ, OQ and PQ protocols. Thermal mapping experience across controlled temperature units. Knowledge of GMP, EU GMP and validation life cycle requirements. Experience managing deviations, investigations and CAPAs. Ability to generate and review validation documentation independently. Excellent communication, technical writing and organisational skills. Desirable experience: New asset introduction projects. Lyophiliser qualification. Sterilisation validation. Utilities qualification (HVAC, WFI, Purified Water, Clean Utilities). Sterile manufacturing or aseptic processing environments. Must have Full Right to Work in the UK for duration of contract. No Sponsorship provided. What you'll get in return Long-term contract opportunity. Outside IR35 engagement. Competitive day rate. Opportunity to work on high-profile qualification and validation projects within a GMP manufacturing environment. Collaborative project team and exposure to significant new asset introduction activities. What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
Your new companyAre you an experienced Regulatory Affairs professional looking to take ownership of life cycle strategy across a dynamic EU portfolio? We're partnering with a leading healthcare organisation to find a Regulatory Affairs Consultant, life cycle management, to join their growing team. This is a fantastic opportunity to play a key strategic and operational role across product life cycle management, working at the intersection of CMC, regulatory strategy, and cross-functional collaboration. You'll contribute to both innovation and maintenance of existing products while managing a small team. Your new role Key Responsibilities Life cycle Management & Submissions Lead end-to-end life cycle management activities including variations, renewals, labelling updates, and aggregate reports. Prepare and submit variation applications via EU procedures (MRP/DCP, Workshare), including complex submissions and super-groupings. Develop submission strategies, including reference member state selection and regulatory pathways Support marketing authorisation applications for early-stage innovation projects Regulatory Strategy Provide strategic regulatory input and technical CMC guidance to cross-functional stakeholders Partner with product development teams to define regulatory requirements, risks, and timelines Contribute to the design and execution of development programmes across the EMEA region Compliance & Governance Ensure compliance with EU and global regulatory requirements and maintain inspection readiness Stay up-to-date with evolving regulatory frameworks, advising the business on impact and opportunity Oversee and maintain accuracy of regulatory systems and documentation Support audits and ensure SOP adherence and continuous process improvement What you'll need to succeed Proven experience in EMEA Regulatory Affairs, ideally within lifecycle management Strong knowledge of EU regulatory procedures (MRP/DCP, variations, PSUSA/aggregate reports) Demonstrated ability to develop and execute regulatory strategy across complex submissions Must have strong working knowledge of worksharing and super grouping Experience in line management or mentoring junior team members Excellent stakeholder engagement and cross-functional collaboration skills What you'll get in return Flexible working options available. What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
Jul 08, 2026
Contractor
Your new companyAre you an experienced Regulatory Affairs professional looking to take ownership of life cycle strategy across a dynamic EU portfolio? We're partnering with a leading healthcare organisation to find a Regulatory Affairs Consultant, life cycle management, to join their growing team. This is a fantastic opportunity to play a key strategic and operational role across product life cycle management, working at the intersection of CMC, regulatory strategy, and cross-functional collaboration. You'll contribute to both innovation and maintenance of existing products while managing a small team. Your new role Key Responsibilities Life cycle Management & Submissions Lead end-to-end life cycle management activities including variations, renewals, labelling updates, and aggregate reports. Prepare and submit variation applications via EU procedures (MRP/DCP, Workshare), including complex submissions and super-groupings. Develop submission strategies, including reference member state selection and regulatory pathways Support marketing authorisation applications for early-stage innovation projects Regulatory Strategy Provide strategic regulatory input and technical CMC guidance to cross-functional stakeholders Partner with product development teams to define regulatory requirements, risks, and timelines Contribute to the design and execution of development programmes across the EMEA region Compliance & Governance Ensure compliance with EU and global regulatory requirements and maintain inspection readiness Stay up-to-date with evolving regulatory frameworks, advising the business on impact and opportunity Oversee and maintain accuracy of regulatory systems and documentation Support audits and ensure SOP adherence and continuous process improvement What you'll need to succeed Proven experience in EMEA Regulatory Affairs, ideally within lifecycle management Strong knowledge of EU regulatory procedures (MRP/DCP, variations, PSUSA/aggregate reports) Demonstrated ability to develop and execute regulatory strategy across complex submissions Must have strong working knowledge of worksharing and super grouping Experience in line management or mentoring junior team members Excellent stakeholder engagement and cross-functional collaboration skills What you'll get in return Flexible working options available. What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.