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.
#J-18808-LjbffrSenior Regulatory Affairs Specialist – Complex Generics in berkeley heights at Unknown Company
This position is listed as full time and onsite.