CMC Regulatory Affairs Manager (Remote)

This manager position within CMC will facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.Responsible for the strategy and execution of the site-specific aspects of the preparation of CMC post-market supplements and facility registrations, with specific emphasis on raw material and component changes.Interfaces with site functions to coordinate preparation of regulatory filings, identification of issues and factors that may implicate a regulatory strategy or activity.Coordinate site-specific change control regulatory assessments with input from the CMC Product teams and the CMC Region representative.Serve as Regulatory CMC voice for product teams by providing the following services:Define minimum regulatory filing requirements for post approval programsProvide regulatory strategy through development of MASP and/or... event GIRSDevelopment of post approval variationsMaintenance of applications (Annual Reports, Distribution Reports, Annual Stability updates)Maintain product compliance through appropriate regulatory filings and activities including regulatory commitmentsSupport Change Management activities as neededRespond to regulatory agency questionsFacilitate agency interactions, including meeting preparation, meetings and briefing documentsLiaise with other Functions in development, operations, and commercial to ensure alignment of global regulatory strategies, timing, execution and plansContribute to the PDTs Variation Master Plan as requiredParticipate as an active member of cross-functional teamsEducation & Experience (Basic):Doctorate degree and 1+ years of directly related experienceORMasters degree and 2 years of directly related experienceORBachelors degree and 5 years of directly related experienceRegulatory Affairs Manager,CMC Regulatory Affairs Manager,Regulatory Affairs,CMC,Change Management,Pharma ,Pharmaceuticals ,Biotech,Biotechnology