Snr CMC Regulatory Specialist
Orange County Metro Area, CA
B.S. required in related scientific discipline with a minimum of 2+ years of regulatory CMC experience and 4+ years of pharmaceutical, biologics or related, experience.
Pharmaceutical manufacturing facility/development laboratory preferred.
Experience in the preparation and management of regulatory submissions including experience in preparation of responses to issues raised by global Health Authorities
Execute and manage the implementation of Regulatory CMC strategy.
Management of regulatory assessments and notifications with change control system.
Functions as primary contact for CMC issues with regulatory authorities for assigned products and projects. Prepares and issues Regulatory Agency Telephone Contact Reports and Meeting Minutes.
Actively participate in project team meetings and provide leadership in meeting submission goals.
Determines nature, scope and format of CMC information to be generated in order to successfully: file and maintain INDs/CTAs; file regulatory dossiers; respond to health authority inquiries; and obtain and maintain market approval for development and approved products.
Manages response team for regulatory agency CMC inquiries.