Regulatory Affairs Specialist
Amneal Pharmaceuticals
August 08, 2026
On-site
Piscataway, NJ
Corporate Functions
Regulatory Affairs Specialist
With minimal supervision, assists with the preparation of high-quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws, including NDA, IND, BLA, Post-Approval Supplements, Annual Reports (AR), and Periodic Adverse Drug Experience Reports (PADERs).
Serves as regulatory lead on cross-functional teams (Clinical, CMC, Quality, Marketing). Assists with tracking project timeliness and follows up with cross-functional stakeholders for required documents.
Coordinates with external vendors, contractors, and consultants for project support activities. Assists in organizing FDA meetings, including compilation of meeting requests and briefing packages with cross-functional contributors.
Qualifications/Requirements:
- Bachelor’s degree in Pharmacy Administration or Chemistry or Pharmaceutical Manufacturing, or related field.
- At least 60 months of experience in the advertised position or in a related position.
Compensation/Work Details (as stated):
- Salary: $117K–$120K per annum
- Hours: 40 hrs/week, 8:30am–5:30pm
- Location: Piscataway, NJ
With minimal supervision, assists with the preparation of high-quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws, including NDA, IND, BLA, Post-Approval Supplements, Annual Reports (AR), and Periodic Adverse Drug Experience Reports (PADERs).
Serves as regulatory lead on cross-functional teams (Clinical, CMC, Quality, Marketing). Assists with tracking project timeliness and follows up with cross-functional stakeholders for required documents.
Coordinates with external vendors, contractors, and consultants for project support activities. Assists in organizing FDA meetings, including compilation of meeting requests and briefing packages with cross-functional contributors.
Qualifications/Requirements:
- Bachelor’s degree in Pharmacy Administration or Chemistry or Pharmaceutical Manufacturing, or related field.
- At least 60 months of experience in the advertised position or in a related position.
Compensation/Work Details (as stated):
- Salary: $117K–$120K per annum
- Hours: 40 hrs/week, 8:30am–5:30pm
- Location: Piscataway, NJ