Regulatory Affairs Specialist
Amneal Pharmaceuticals
August 29, 2026
On-site
Piscataway, NJ
Corporate Functions
Regulatory Affairs Specialist
Responsibilities:
- With minimal supervision, assist with preparation of high-quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws.
- Support submissions including: NDA, IND, BLA, post-approval supplements, annual reports (AR), and periodic adverse drug experience reports (PADERs).
- 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.
- Assist in organizing FDA meetings, including compilation of meeting requests and briefing packages with cross-functional contributors.
Qualifications:
- 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.
Salary: $117K - $120K per annum.
Hours: 40 hrs/wk (8:30am – 5:30pm).
Location: Piscataway, NJ.
Responsibilities:
- With minimal supervision, assist with preparation of high-quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws.
- Support submissions including: NDA, IND, BLA, post-approval supplements, annual reports (AR), and periodic adverse drug experience reports (PADERs).
- 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.
- Assist in organizing FDA meetings, including compilation of meeting requests and briefing packages with cross-functional contributors.
Qualifications:
- 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.
Salary: $117K - $120K per annum.
Hours: 40 hrs/wk (8:30am – 5:30pm).
Location: Piscataway, NJ.