Manager, Regulatory Affairs
Orange County Metro Area, CA
This position will execute CMC projects within the Global Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) organization by actively contributing to the development and implementation of global CMC regulatory strategies throughout the lifecycle of biologics and device/biologics combination products.
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.
Administers preparation of briefing and presentation materials for Regulatory Agency meetings.
Represents Regulatory Affairs CMC on project teams for assigned products/projects.
Regulatory environment, regulatory submission and/or pharmaceutical healthcare environment.
Business and personal computer hardware and software applications.
Excellent written and verbal communication, presentation, and facilitation skills
Collaborate with management to develop appropriate regulatory strategy.
Interpret global regulations and apply Health Authority guidance to the development of CMC regulatory documentation.
Establish strong working relationships within the project teams by proactively managing global CMC strategies, submissions, and timelines.
Work independently to prioritize and manage multiple projects and assignments.
Ability to build bridges between diverse groups of stakeholders.
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.
Global registration support.
Perform regulatory assessments in a cGMP change control environment.
Sound basis of Scientific (Training/Communications) knowledge in multiple areas
Demonstrated ability to prepare and manage ensure thoroughness, and accuracy of global CMC dossiers.
Ability to handle multiple assignments and prioritize work independently.
Experience with biologics products
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.