Associate Director, CMC Regulatory Science - UK
Core
Lead CMC regulatory strategy for UK-manufactured and UK-licensed mRNA products from development through commercialization and post-approval lifecycle.
Role type
Senior IC regulatory science leader (CMC)
Builds
Regulatory submissions and compliance frameworks for mRNA medicines
Domain
Biopharmaceuticals / mRNA / Regulatory Science
Required skills
CMC regulatory strategy, MHRA interactions, regulatory submissions (CTD), manufacturing change assessment, cross-functional leadership, risk mitigation, global regulatory alignment, process excellence, digital innovation in regulation, stakeholder influence
Preferred skills
Experience with Generative AI tools for regulatory tasks, deep knowledge of UK CMC regulations
Technologies
CTD, Generative AI tools
Responsibilities
Define and lead CMC regulatory strategy for assigned products; Drive CMC regulatory submissions; Lead regulatory assessment of manufacturing and quality changes; Serve as primary point of contact for MHRA interactions; Translate evolving regulatory expectations into actionable strategies; Provide strategic oversight of CMC compliance and regulatory risk; Lead cross-functional regulatory strategy and decision-making; Shape global CMC regulatory approaches; Champion regulatory process excellence and innovation; Explore digital innovation and emerging regulatory technologies; Represent CMC regulatory strategy in governance discussions; Lead complex regulatory decisions; Mentor colleagues
Seniority
Senior, strategic leadership with hands-on expertise