About this opportunity
Breckenridge Pharmaceutical, Inc. lists this Senior Regulatory Affairs Specialist – Complex Generics opportunity in berkeley heights, New Jersey. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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.
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.