About this opportunity
Breckenridge Pharmaceutical lists this Regulatory CMC Lead, Sterile Injectables & Generics opportunity in berkeley heights, New Jersey. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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,
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Worksite address
berkeley heights, NJ, 07922, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.