Serve as the regulatory CMC representative on project teams.
Provides CMC regulatory support and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, Supply Chain and Regulatory colleagues, as well as third party laboratories, global collaborations partners and contract manufacturers.
Manage interactions with FDA and other global regulatory authorities for assigned project(s) to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which present CMC information.
Author and lead CMC content for Health Authority meeting briefing packages, including development of CMC strategy, preparation of CMC-related questions, supporting data summaries, and responses to Health Authority feedback, in collaboration with Global Regulatory and cross-functional teams.
Develop and implement effective regulatory CMC strategies for global submissions knowing the life cycle of drug product from R&D through commercialization and can interpret and apply local regulations and guidance’s to the life cycle of a drug product.
Actively participate as a member of global regulatory teams and CMC subteams.
Support and manages regulatory aspects of CMC Operations including authoring, reviewing and or approving SOP’s, CAPA’s, etc.

Minimum 8+ years of experience in a global CMC regulatory affairs position with expertise in biologics and deep experience in development products and commercial product lifecycle including Phase 1-3, and marketed products)
BS/BA Biochemistry, Biology, or Pharmaceutical Science; Advanced degree preferred.
Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint), Veeva Data Management System
Strong knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issues.
Demonstrated experience in effective collaboration with multiple stakeholders both internally and externally including FDA and other Health Authorities.
Demonstrated ability to coach, train and mentor teams.
Strong negotiating skills and ability to think creatively and develop creative solutions.

Associate Director, Regulatory Affairs, CMC

Key skills