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Senior Director Regulatory Affairs
2 months ago
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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