Regulatory Affairs Specialist
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Job overview
Amneal Pharmaceuticals is hiring a Regulatory Affairs Specialist. The Regulatory Affairs Specialist assists with preparing high-quality regulatory submissions to the FDA, ensuring compliance with guidelines and federal laws. This role involves working on various applications such as NDA, IND, BLA, Post-Approval Supplements, Annual Reports, and PADERs. The incumbent will serve as a regulatory lead on cross-functional teams and coordinate with external vendors.
Key focus areas include Assist with preparation of high-quality regulatory submissions to the FDA, Serve as regulatory lead on cross functional teams, and Assist in tracking project timeliness.
Successful candidates bring Bachelor's In Pharmacy Administration Or Chemistry Or Pharmaceutical Manufacturing Or Related Field and 60 Months Experience. Important skills include Regulatory Submissions, New Drug Application, Biologics License Applications, Post-Approval Supplements, Annual Reports, and Periodic Adverse Drug Experience Reports.
Skills & qualifications
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Full job description
AMNEAL PHARMACEUTICALS
Regulatory Affairs Specialist: With minimal supervision assists with the preparation of high-quality regulatory submissions to the Food and Drug Administration (FDA) as required, within company timelines and in accordance with regulatory guidelines and applicable federal laws. This includes, but is not limited, to New Drug Application (NDA), Investigational New Drug Application (IND), Biologics License Applications (BLA), Post-Approval Supplements, Annual Reports (AR), and Periodic Adverse Drug Experience Reports (PADERs). The incumbent serves as regulatory lead on cross functional teams including Clinical, CMC, Quality, and Marketing. Assists in tracking project timeliness and follows up cross functionally for required documents.
Coordinates with external vendors, contractors and consultants for project support activities. Assists in organizing meetings with FDA including compilation of meeting requests and briefing packages with cross functional contributors. Must have at least a Bachelor’s degree in Pharmacy Administration or Chemistry or Pharmaceutical Manufacturing, or related field . Must have at least 60 months of experience in the advertised position or in a related position.
Salary: $117K - $120K per annum.
Hours: 40 hrs/wk 8:30am – 5:30pm
Location: Piscataway, NJ
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