We're looking for a Regulatory Affairs Manager, working in the Pharmaceuticals & Medical Products industry in Irvine, California, United States.
Functions as primary contact for CMC issues with regulatory authorities for assigned products and projects.
Executes and manages the implementation of regulatory CMC strategy.
Manages response team for regulatory agency CMC inquiries.
Determines nature, scope and format of CMC information to be generated in order to successfully: files and maintain INDs/CTAs; files regulatory dossiers; responds to health authority inquiries; and obtains and maintains market approval for development and approved products.
The pay range we're offering is 70 to 75 per hour. This position may present an opportunity to go permanent.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years’ experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
B.S. required in related scientific discipline
2 plus years of regulatory CMC experience and 4 plus years of pharmaceutical, biologics or related, experience.