Senior Regulatory Affairs Specialist – Complex Generics

Breckenridge Pharmaceutical, Inc. in Berkeley Heights, NJ, is seeking a Regulatory Affairs Senior Associate to manage regulatory submissions (ANDAs and post-approval changes) and lifecycle support for complex generics and drug-device combinations.

You will author eCTD sections, advise on filing strategies, prepare GDUFA III meeting packages, and collaborate with cross-functional teams to ensure FDA compliance and timely filings.

We have an opening for a Senior Regulatory Affairs Specialist – Complex Generics in Berkeley Heights, NJ, United States within Legal, Management & Operations.

We aim to respond to suitable candidates as soon as possible.

Full responsibilities and requirements are described in the listing above.

Learn more about the Senior Regulatory Affairs Specialist – Complex Generics role in the description above.

We appreciate your interest in this position.

Join Breckenridge Pharmaceutical, Inc. and contribute to our ongoing work.