Regulatory Affairs Specialist

Amneal

3d • Onsite

About The Position

With minimal supervision, the Regulatory Affairs Specialist 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.

Requirements

• Bachelor’s degree in Pharmacy Administration, Chemistry, Pharmaceutical Manufacturing, or related field.
• At least 60 months of experience in the advertised position or in a related position.

Responsibilities

• Assist with the preparation of high-quality regulatory submissions to the FDA.
• Serve as regulatory lead on cross-functional teams (Clinical, CMC, Quality, Marketing).
• Track project timeliness and follow up cross-functionally for required documents.
• Coordinate with external vendors, contractors, and consultants for project support activities.
• Assist in organizing meetings with FDA, including compilation of meeting requests and briefing packages.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior