What are the responsibilities and job description for the Regulatory Affairs Specialist position at BioTalent?
Regulatory Affairs Specialist
Pharma & Medical Devices | Contract Manufacturing
We’re looking for a sharp, motivated Regulatory Affairs Specialist to join a growing contract manufacturing team supporting pharmaceutical and medical products. This is a hands‑on role for someone early in their regulatory career who’s ready to build depth, gain exposure, and work directly with clients.
What You’ll Do
- Support regulatory submissions with a strong pharma focus
- Assist with U.S. FDA filings, including exposure to ANDA submissions
- Help manage state regulatory reporting and compliance activities
- Collaborate cross‑functionally with quality, manufacturing, and client teams
- Participate in client‑facing interactions and regulatory communications
- Learn, grow, and take on increasing ownership of regulatory deliverables
What We’re Looking For
- 1–4 years of Regulatory Affairs experience (pharma experience preferred)
- Familiarity with FDA submission processes; ANDA exposure is a plus
- Detail‑oriented, organized, and comfortable working in regulated environments
- Polished communicator who can represent the company professionally
- Curious, trainable, and eager to grow in a fast‑paced setting
Why This Role
- Broad exposure across pharma and medical products
- Real responsibility early in your career
- Opportunity to work closely with experienced regulatory professionals
- Contract manufacturing environment with variety—not repetition
If you’re ready to deepen your regulatory expertise while gaining client exposure and hands‑on experience, we’d love to hear from you.
Salary : $70,000 - $90,000