Regulatory CMC Lead, Sterile Injectables & Generics

Breckenridge Pharmaceutical is seeking a Regulatory Affairs Manager to support regulatory CMC strategies and submissions for generic products, including complex sterile injectables and drug-device combinations. You will prepare, review, and submit filings throughout the product lifecycle while ensuring FDA compliance and eCTD standards.

Reporting to the Director of Regulatory Affairs, you will lead regulatory activities for assigned programs, collaborate with R&D, Analytical Development,