Regulatory Affairs Specialist

About the role

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).

Responsibilities

• Serve as regulatory lead on cross-functional teams including Clinical, CMC, Quality, and Marketing.
• Assist in tracking 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 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 a related position.

Pay

$117K - $120K per annum.

Schedule

40 hours per week, 8:30 AM – 5:30 PM.

Location

Piscataway, NJ