Senior Director Regulatory Affairs

Senior/Executive Director of Regulatory AffairsHybrid 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 responsibilitiesProvide 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.