Exact Sciences Corporation
Lead Regulatory Affairs Manager, International page is loaded Lead Regulatory Affairs Manager, Internationallocations: DE - Cologne: UK - London: Sweden: IT - Milantime type: Full timeposted on: Posted Todayjob requisition id: R26-12786 Help us change lives At Exact Sciences, we're helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you're working to help others. Position Overview The Lead Regulatory Affairs Manager, International will support or lead the creation and submission of product Technical Files/Standard Technical Documentation and other submission related documents for market authorizations in targeted markets and countries. The Lead Regulatory Affairs Manager, International supports or leads the creation and execution of regulatory strategy for assigned projects, including new product development, product changes, and manufacturing improvement initiatives. This role assists in creating, developing, and implementing global regulatory affairs procedures and educating others on global regulatory expectations and requirements. Essential Duties Include but are not limited to the following: Participate, lead or support the preparation and maintenance of regulatory submissions and other premarket registrations to acquire appropriate commercial distribution approvals and/or clearances. Support or lead as needed regulatory strategy development, document appropriate regulatory strategy for proposed new products and markets and initiate necessary activities by working with project teams and regulatory team members as needed. Control and maintain regulatory records. Represent Regulatory Affairs on project teams by attending team meetings and providing the required plans, procedures and regulatory decisions. Manage distributors and RA consultants to ensure global registrations are completed on time and maintained. Review and approve documents and product changes for regulatory compliance, determining if a new premarket application is required. Review technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry. Review and approve product labeling and marketing material. Provide Regulatory reviews and approvals of advertising, promotional and external product training materials in compliance with applicable regulatory and trade requirements and Exact Sciences Medical, Legal and Regulatory (MLR) review process. Demonstrate continuous pursuit of global regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including IVDR, UK CA, FDA and Health Canada regulations and policies applying to In Vitro Diagnostic medical devices including, PMAs, 510(k)s, labeling and promotional materials, global registration, and technical writing. Experience with regulators in the Middles East and/or Latin America will be a plus. Strong technical writing skills. Effective communicator: ability to convey messages in a logical and concise manner. Consistently reinforce regulatory expectations and requirements. Exceptional attention to detail. Strong organizational skills. Independent self-starter; manage time effectively and complete tasks on-time with minimal supervision. Flexible and able to self-manage multiple priorities. Ability to work effectively in multinational/multicultural environments. Adapt readily to changes in workload, staffing, and scheduling. Comply with management direction. Seek assistance from supervisor in identifying and reporting problems or concerns relating to job functions. Conduct self in a professional manner with coworkers, management, customers, and others. Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. Support and comply with the company's Quality Management System policies and procedures. Regular and reliable attendance. Ability to work designated schedule. Ability to work nights and/or weekends as needed. Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 75% of a typical working day. Ability to work on a computer and phone simultaneously. Ability to use a telephone through a headset. Ability to travel 30% of working time away from work location, may include overnight/weekend travel. Minimum Qualifications Bachelor's degree in Physical or Life Sciences; or a High School Diploma/ General Education Degree (GED) and at least 5 years of relevant career experience in lieu of Bachelor's degree. 7+ years relevant experience in a regulated pharmaceutical or medical device environment. Basic computer skills to include Internet navigation, Email usage, and word processing. Proficient in Microsoft Office. Authorization to work in the European Union. Demonstrated ability to perform the Essential Duties of the position with or without accommodation. Preferred Qualifications Bachelor's degree in Science or Health related discipline. Professional working knowledge with reviewing and approving product advertising and creating product labeling. Professional working knowledge with adverse event reporting and is familiar with post-market surveillance and vigilance requirements. success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.to stay updated on the latest news and opportunities at Exact Sciences.
Lead Regulatory Affairs Manager, International page is loaded Lead Regulatory Affairs Manager, Internationallocations: DE - Cologne: UK - London: Sweden: IT - Milantime type: Full timeposted on: Posted Todayjob requisition id: R26-12786 Help us change lives At Exact Sciences, we're helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you're working to help others. Position Overview The Lead Regulatory Affairs Manager, International will support or lead the creation and submission of product Technical Files/Standard Technical Documentation and other submission related documents for market authorizations in targeted markets and countries. The Lead Regulatory Affairs Manager, International supports or leads the creation and execution of regulatory strategy for assigned projects, including new product development, product changes, and manufacturing improvement initiatives. This role assists in creating, developing, and implementing global regulatory affairs procedures and educating others on global regulatory expectations and requirements. Essential Duties Include but are not limited to the following: Participate, lead or support the preparation and maintenance of regulatory submissions and other premarket registrations to acquire appropriate commercial distribution approvals and/or clearances. Support or lead as needed regulatory strategy development, document appropriate regulatory strategy for proposed new products and markets and initiate necessary activities by working with project teams and regulatory team members as needed. Control and maintain regulatory records. Represent Regulatory Affairs on project teams by attending team meetings and providing the required plans, procedures and regulatory decisions. Manage distributors and RA consultants to ensure global registrations are completed on time and maintained. Review and approve documents and product changes for regulatory compliance, determining if a new premarket application is required. Review technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry. Review and approve product labeling and marketing material. Provide Regulatory reviews and approvals of advertising, promotional and external product training materials in compliance with applicable regulatory and trade requirements and Exact Sciences Medical, Legal and Regulatory (MLR) review process. Demonstrate continuous pursuit of global regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including IVDR, UK CA, FDA and Health Canada regulations and policies applying to In Vitro Diagnostic medical devices including, PMAs, 510(k)s, labeling and promotional materials, global registration, and technical writing. Experience with regulators in the Middles East and/or Latin America will be a plus. Strong technical writing skills. Effective communicator: ability to convey messages in a logical and concise manner. Consistently reinforce regulatory expectations and requirements. Exceptional attention to detail. Strong organizational skills. Independent self-starter; manage time effectively and complete tasks on-time with minimal supervision. Flexible and able to self-manage multiple priorities. Ability to work effectively in multinational/multicultural environments. Adapt readily to changes in workload, staffing, and scheduling. Comply with management direction. Seek assistance from supervisor in identifying and reporting problems or concerns relating to job functions. Conduct self in a professional manner with coworkers, management, customers, and others. Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. Support and comply with the company's Quality Management System policies and procedures. Regular and reliable attendance. Ability to work designated schedule. Ability to work nights and/or weekends as needed. Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 75% of a typical working day. Ability to work on a computer and phone simultaneously. Ability to use a telephone through a headset. Ability to travel 30% of working time away from work location, may include overnight/weekend travel. Minimum Qualifications Bachelor's degree in Physical or Life Sciences; or a High School Diploma/ General Education Degree (GED) and at least 5 years of relevant career experience in lieu of Bachelor's degree. 7+ years relevant experience in a regulated pharmaceutical or medical device environment. Basic computer skills to include Internet navigation, Email usage, and word processing. Proficient in Microsoft Office. Authorization to work in the European Union. Demonstrated ability to perform the Essential Duties of the position with or without accommodation. Preferred Qualifications Bachelor's degree in Science or Health related discipline. Professional working knowledge with reviewing and approving product advertising and creating product labeling. Professional working knowledge with adverse event reporting and is familiar with post-market surveillance and vigilance requirements. success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.to stay updated on the latest news and opportunities at Exact Sciences.
Oman Shell
South & EE Team Regulatory Affairs Lead page is loaded South & EE Team Regulatory Affairs Leadlocations: London York Roadtime type: Full timeposted on: Posted Todayjob requisition id: R199649, United Kingdom Job Family Group: Corporate Relations Worker Type: Regular Posting Start Date: April 16, 2026 Business Unit: Trading and Supply Experience Level: Experienced Professionals Job Description: If you are a regulatory expert, a leader in your field with a passion for energy markets and a commercial mindset this could be your chance to make a difference in the energy industry. You will play a key role in growing the Shell businesses by shaping the South and East Europe regulatory framework for gas, biomethane and power and advising business developers and traders on commercial positions. Where you fit in The EU regulatory framework for is rapidly evolving. Understanding the complex regulatory environment and translating regulations into winning and defensive commercial structures, influencing the shaping up of new policies and regulations affecting the gases and power value chains in the region will be key success factors for Shell to outcompete others in the market and deliver on its growth ambitions.You are going to be a key part of our Shell Energy Europe and Africa Regulatory Team, a team of regulatory experts who are passionate about: Delivering value for Shell by identifying key regulatory risks and mitigating strategies to protect Shell's existing and aspired commercial positions; Developing opportunities to change existing regulations to enable business growth and Actively pursuing and delivering regulatory change by playing a thought leadership role in external regulatory processes.As the South Regulatory Team Lead you will to work closely with business developers and traders to provide senior regulatory expertise, guidance and support to enhance business performance and enable business growth. In particular, with regard to policy, legislative, regulatory and market design in the South and East region, your role will be to: Lead, develop and nurture a team of regulatory experts focusing on South and Eastern EU gases and power markets Lead on monitoring national authorities on policy, regulatory and market design issues having a commercial impact on our business Lead on the development of insights into the regional gas regulatory and market design structures and trends for natural gas, biomethane and power Use this knowledge to derive and facilitate commercial strategies to generate tangible financial results in the short, medium term and long term Lead on engaging commercial and functional teams, including the local sales offices and the local operations teams, to develop joint views on regulatory and market design opportunities, risks and threats Leveraging on your professional regulatory network, lead on the development and execution of influencing and advocacy strategies to secure value protection, new opportunities and business growth Rrepresent Shell in relevant trade and industry associations and their committees and working groups. This will likely involve external leadership roles, e.g. working group chair. Particularly for new business activities, market entries or customer value propositions, provide support to the business in identifying relevant rules and regulations and establishing efficient and effective processes so that business is conducted in full compliance. Maintain close liaison with the Corporate Relations team and work closely with them to effectively influence political stakeholders.The role requires leadership and regulatory skills to motivate and drive high quality delivery of a team of regulatory experts. Degree, preferably in economics, engineering or political science. Substantial knowledge of gas and/or biomethane and/or power markets in South and East Europe and experience of the changing regulatory, commercial, customer and competitor playing field. Ability to distil a broad array of data and knowledge, together with specialist and strategic advice and synthesize it into a clear consistent storyline. Ability to develop and execute effective lobbying strategies with a tangible impact. Self-starter, able to initiate new opportunities from a broadly defined set of objectives, meet/exceed performance targets and motivate others to do likewise. Excellent interpersonal and communication skills in written and spoken English essential. Fluency in one other South and East region language is a strong advantage. An existing strong network in the regulatory space, a strong external focus, an ability to network and develop relationships, as well as diplomatic skills. High commercial acumen and creativity allowing the incumbent to respond adequately (and in many cases under time pressure and in public fora) to challenges in negotiations with highly experienced and commercially astute regulatory professionals. Ability and experience in leading, supervising and motivating a team of regulatory experts and ensure high quality delivery. What we offer You bring your skills and experience to Shell and in return you work with talented, committed people on one of the most important challenges facing our planet. You'll have the opportunity to develop the skills you need to grow in an environment where we value honesty, integrity, and respect for one another. You'll be able to balance your priorities as you become the best version of yourself. Progress as a person as we work on the energy transition together. Continuously grow the transferable skills you need to get ahead. Work at the forefront of technology, trends, and practices. Collaborate with experienced colleagues with unique expertise. Achieve your balance in a values-led culture that encourages you to be the best version of yourself. Benefit from a range of flexible working options. Perform at your best with a competitive starting salary and annual performance related salary increase - our pay and benefits packages are considered to be among the best in the world. Take advantage of paid parental leave, including for non-birthing parents. Join an organisation working to become one of the most diverse and inclusive in the world. We strongly encourage applicants of all genders, ages, ethnicities, cultures, abilities, sexual orientation, and life experiences to apply. Grow as you progress through diverse career opportunities in national and international teams. Gain access to a wide range of training and development programmes.We are committed to attracting a broader and more diverse pool of candidates. If this position doesn't feel like the perfect fit for your qualifications right now, we'd still love to hear from you.Shell is working to advance an inclusive, psychologically safe and accessible environment where people with disabilities can excel. If you require any accommodations or accessibility adjustments (e.g. assistive technology, communication support, or other) during the application or interview process, please let us know when prompted in your application. We strive to ensure that our process and workplace is accessible to everyone and are dedicated to making reasonable adjustments to support your needs. Shell in The United Kingdom Shell UK remains one of the North Sea's biggest producers, supplying around 10% of the UK's total oil and gas needs. But perhaps the most recognisable face of Shell in the UK is our network of over 1,000 Shell-branded service stations.In the years ahead, as the UK looks to strengthen energy security and deliver its 2050 net-zero goal, Shell UK aims to play a crucial role. We aim to be a major investor in the UK energy system by helping our customers decarbonise with a focus on transport and industry.- DISCLAIMER: Please note: We occasionally amend or withdraw Shell jobs and reserve
South & EE Team Regulatory Affairs Lead page is loaded South & EE Team Regulatory Affairs Leadlocations: London York Roadtime type: Full timeposted on: Posted Todayjob requisition id: R199649, United Kingdom Job Family Group: Corporate Relations Worker Type: Regular Posting Start Date: April 16, 2026 Business Unit: Trading and Supply Experience Level: Experienced Professionals Job Description: If you are a regulatory expert, a leader in your field with a passion for energy markets and a commercial mindset this could be your chance to make a difference in the energy industry. You will play a key role in growing the Shell businesses by shaping the South and East Europe regulatory framework for gas, biomethane and power and advising business developers and traders on commercial positions. Where you fit in The EU regulatory framework for is rapidly evolving. Understanding the complex regulatory environment and translating regulations into winning and defensive commercial structures, influencing the shaping up of new policies and regulations affecting the gases and power value chains in the region will be key success factors for Shell to outcompete others in the market and deliver on its growth ambitions.You are going to be a key part of our Shell Energy Europe and Africa Regulatory Team, a team of regulatory experts who are passionate about: Delivering value for Shell by identifying key regulatory risks and mitigating strategies to protect Shell's existing and aspired commercial positions; Developing opportunities to change existing regulations to enable business growth and Actively pursuing and delivering regulatory change by playing a thought leadership role in external regulatory processes.As the South Regulatory Team Lead you will to work closely with business developers and traders to provide senior regulatory expertise, guidance and support to enhance business performance and enable business growth. In particular, with regard to policy, legislative, regulatory and market design in the South and East region, your role will be to: Lead, develop and nurture a team of regulatory experts focusing on South and Eastern EU gases and power markets Lead on monitoring national authorities on policy, regulatory and market design issues having a commercial impact on our business Lead on the development of insights into the regional gas regulatory and market design structures and trends for natural gas, biomethane and power Use this knowledge to derive and facilitate commercial strategies to generate tangible financial results in the short, medium term and long term Lead on engaging commercial and functional teams, including the local sales offices and the local operations teams, to develop joint views on regulatory and market design opportunities, risks and threats Leveraging on your professional regulatory network, lead on the development and execution of influencing and advocacy strategies to secure value protection, new opportunities and business growth Rrepresent Shell in relevant trade and industry associations and their committees and working groups. This will likely involve external leadership roles, e.g. working group chair. Particularly for new business activities, market entries or customer value propositions, provide support to the business in identifying relevant rules and regulations and establishing efficient and effective processes so that business is conducted in full compliance. Maintain close liaison with the Corporate Relations team and work closely with them to effectively influence political stakeholders.The role requires leadership and regulatory skills to motivate and drive high quality delivery of a team of regulatory experts. Degree, preferably in economics, engineering or political science. Substantial knowledge of gas and/or biomethane and/or power markets in South and East Europe and experience of the changing regulatory, commercial, customer and competitor playing field. Ability to distil a broad array of data and knowledge, together with specialist and strategic advice and synthesize it into a clear consistent storyline. Ability to develop and execute effective lobbying strategies with a tangible impact. Self-starter, able to initiate new opportunities from a broadly defined set of objectives, meet/exceed performance targets and motivate others to do likewise. Excellent interpersonal and communication skills in written and spoken English essential. Fluency in one other South and East region language is a strong advantage. An existing strong network in the regulatory space, a strong external focus, an ability to network and develop relationships, as well as diplomatic skills. High commercial acumen and creativity allowing the incumbent to respond adequately (and in many cases under time pressure and in public fora) to challenges in negotiations with highly experienced and commercially astute regulatory professionals. Ability and experience in leading, supervising and motivating a team of regulatory experts and ensure high quality delivery. What we offer You bring your skills and experience to Shell and in return you work with talented, committed people on one of the most important challenges facing our planet. You'll have the opportunity to develop the skills you need to grow in an environment where we value honesty, integrity, and respect for one another. You'll be able to balance your priorities as you become the best version of yourself. Progress as a person as we work on the energy transition together. Continuously grow the transferable skills you need to get ahead. Work at the forefront of technology, trends, and practices. Collaborate with experienced colleagues with unique expertise. Achieve your balance in a values-led culture that encourages you to be the best version of yourself. Benefit from a range of flexible working options. Perform at your best with a competitive starting salary and annual performance related salary increase - our pay and benefits packages are considered to be among the best in the world. Take advantage of paid parental leave, including for non-birthing parents. Join an organisation working to become one of the most diverse and inclusive in the world. We strongly encourage applicants of all genders, ages, ethnicities, cultures, abilities, sexual orientation, and life experiences to apply. Grow as you progress through diverse career opportunities in national and international teams. Gain access to a wide range of training and development programmes.We are committed to attracting a broader and more diverse pool of candidates. If this position doesn't feel like the perfect fit for your qualifications right now, we'd still love to hear from you.Shell is working to advance an inclusive, psychologically safe and accessible environment where people with disabilities can excel. If you require any accommodations or accessibility adjustments (e.g. assistive technology, communication support, or other) during the application or interview process, please let us know when prompted in your application. We strive to ensure that our process and workplace is accessible to everyone and are dedicated to making reasonable adjustments to support your needs. Shell in The United Kingdom Shell UK remains one of the North Sea's biggest producers, supplying around 10% of the UK's total oil and gas needs. But perhaps the most recognisable face of Shell in the UK is our network of over 1,000 Shell-branded service stations.In the years ahead, as the UK looks to strengthen energy security and deliver its 2050 net-zero goal, Shell UK aims to play a crucial role. We aim to be a major investor in the UK energy system by helping our customers decarbonise with a focus on transport and industry.- DISCLAIMER: Please note: We occasionally amend or withdraw Shell jobs and reserve