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Senior Director Regulatory Affairs

2 months ago

Bristol, United Kingdom Life Science People Full time

Senior/Executive Director of Regulatory Affairs

Hybrid working


What you’ll be doing:


  • Strategize for Success: Lead the global regulatory strategy for products.
  • Drive Regulatory Excellence: Manage strategic regulatory documents and interactions with global agencies.
  • Collaborate for Impact: Align regulatory strategies with product development plans, working with diverse teams.


Essential skills and requirements:


  • Experience in the regulation of biologics, including immunomodulating therapies and vaccines, is highly valued.
  • 10+ years experience in Regulatory Affairs
  • In-depth experience with clinical and non-clinical regulatory aspects of products in development.
  • Strong experience with biologics registration requirements in Europe and familiarity with international regulations (US FDA, UK MHRA).
  • Solid understanding of Regulatory Life Cycle Management and eCTD format for regulatory filings.
  • Demonstrated ability in drafting and organizing regulatory submissions, amendments, and supplements.


Duties and responsibilities


  • Provide regulatory affairs expertise to clients seeking regulatory strategic input to their development programmes.
  • Applies senior regulatory affairs experience in other areas for the conduct of client projects.
  • Supports BD and Marketing efforts to support company growth including client pitches, input into proposals, social media activity and speaking events.
  • Line management and leadership of a team of Regulatory Affairs managers.
  • Application of expertise in the area of product development regulatory strategy over several years.
  • Advise clients on a strategic level covering a broad range of product development stages, geography, therapy areas and products.

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