Regulatory Affairs Labelling

Join Our Team as a Regulatory Labeling Manager!

Are you passionate about regulatory affairs in the pharmaceutical industry? Do you have a knack for strategic labeling and a desire to make a meaningful impact on product life cycle management? If so, we have an exciting opportunity for you!

Position: Regulatory Labeling Manager
Contract Type: Fixed Term Contract
Contract Length: 6 months
Daily Rate: £487.50 - £525.00
Working Pattern: Full Time

About the Role:

As a Regulatory Labeling Manager, you will play a pivotal role in our Regulatory Affairs Function. You'll lead and support product teams in developing, optimizing, and implementing regulatory labelling strategies that span the entire product life cycle. Your expertise will ensure that our Core Data Sheets (CDS) are not just maintained but are top-notch and compliant across markets.

Key Responsibilities:

• Strategic Leadership: Drive and optimize the strategy for the creation and maintenance of CDS. Provide guidance and expertise to product teams on supporting documents.
• Document Management: Author and maintain CDS while managing the processes in collaboration with regulatory product leads and cross-functional teams.
• Product Information Packages: Spearhead the strategy for EU and US product information documents. Author and maintain these critical documents and lead responses to health authority questions.
• Regulatory Recommendations: Offer strategic insights regarding acceptable labeling in regional markets, collaborating with relevant functions to ensure compliance.
• Implementation Support: Guide the implementation of CDS into Local Product Labels and manage any local label deviations.
• Regulatory Guidance: Provide in-depth guidance on labeling regulatory issues, including legislation, guidelines, and procedures to project teams.
• Process Improvement: Lead initiatives for establishing or enhancing working processes and standards within the department.

What You Bring:

• A Bachelor's degree or equivalent in life sciences or relevant fields.
• In-depth insight into regulatory affairs, particularly in strategic labelling; knowledge of market access is a plus!
• Proven ability to lead cross-functional Matrix teams with strong influencing skills.
• Excellent interpersonal and verbal communication skills that shine in collaborative environments.

Why Join Us?

This is your chance to be part of an innovative team that's dedicated to excellence in the pharmaceutical sector. You'll work in a dynamic environment where your contributions truly matter, and you'll be surrounded by like-minded professionals who share your passion for regulatory affairs.

We use generative AI tools to support our candidate screening process. This helps us ensure a fair, consistent, and efficient experience for all applicants. Rest assured, all final decisions are made by our hiring team, and your application will be reviewed with care and attention.

Adecco is a disability-confident employer. It is important to us that we run an inclusive and accessible recruitment process to support candidates of all backgrounds and all abilities to apply. Adecco is committed to building a supportive environment for you to explore the next steps in your career. If you require reasonable adjustments at any stage, please let us know and we will be happy to support you.