Job Description

REQUIRED SKILLS

• Strong and proven experience in Regulatory Affairs within the (bio)pharmaceutical industry.
• Strong understanding of UK and Ireland regulatory frameworks.
• An excellent communicator, with the ability to lead strategic cross functional team discussions
• Proficiency in MS Office, regulatory databases (e.g., Cortellis), and electronic document management systems.
• Ability to work independently and manage multiple priorities.
  Additional Information

ABOUT THIS ROLE

Joining us as a Senior Manager, Regulatory Affairs UK & Ireland, you will be responsible for supporting and maintaining country-specific regulatory and R&D compliance activities across our pipeline and product portfolio, in line with the company’s strategy and the management of benefit/risk activities. You will play a key role driving regulatory strategies in alignment with business objectives, in addition to ensuring compliance.
In this role you will work closely with the in-country Regulatory Head, Global Regulatory Affairs colleagues and R&D teams, as well as with various local functions such as Medical, Marketing, Market Access and Quality Assurance. You will have close interactions with external regulatory authorities, advisory committees and cooperative groups.
This is a hybrid role, requiring attendance at our Maidenhead offices 2-3 days per week.

WHAT YOU’LL DO

• Lead and support local regulatory activities for the UK/Ireland affiliate, reporting through the Global Regulatory Affairs (GRA) group.
• Manage pre- and post-approval procedures for pipeline and marketed products, including orphan applications, ILAP, PIPs, Scientific Advice, EAMs, MAA filings, and post-approval maintenance.
• Oversee local labelling processes and ensure timely updates for centralized products in Ireland.
• Review and approve packaging, artwork, and educational materials.
• Maintain strong relationships with regulatory authorities, advisory committees, and industry groups.
• Monitor and provide insights on regulatory intelligence to support business strategy.
• Ensure operational compliance with in-country regulatory responsibilities.
• Represent Biogen in local trade associations and regulatory groups as needed.