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.

Join us at Breckenridge Pharmaceutical, Inc. as our next Senior Regulatory Affairs Specialist – Complex Generics in Berkeley Heights, NJ, United States.

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.

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This posting is for the Senior Regulatory Affairs Specialist – Complex Generics role at Breckenridge Pharmaceutical, Inc., based in Berkeley Heights, NJ, United States.