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Regulatory Affairs Specialist
Job in
Indiana Borough, Indiana County, Pennsylvania, 15705, USA
Listed on 2026-10-06
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-06
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist
Job Description & How to Apply Below
Regulatory Affairs Specialist supporting global and regional regulatory strategies across product lifecycle stages in biopharma.
Responsibilities- prepare and review regulatory submissions (INDs, NDAs, BLAs, safety reports) in eCTD format;
- collaborate with cross-functional teams (Medical Writing, CMC, Clinical Ops);
- support health authority interactions, including briefing packages and IR responses;
- ensure compliance in post-marketing activities like labeling and manufacturing updates;
- maintain regulatory documentation and databases.
- Bachelor’s in a scientific/healthcare field;
- minimum 3 years’ regulatory experience in biopharma or CROs;
- hands‑on experience with US FDA submissions, eCTD, and 21 CFR regulations;
- familiarity with GxP and ICH guidelines;
- proficiency with document management systems such as Veeva Vault RIM;
- strong scientific writing and project management skills.
- RAC certification.
- US FDA regulatory expertise, experience with IND/NDA/BLA submissions, cross‑functional collaboration, lifecycle management, and compliance in an FDA-regulated environment.
hybrid in Indianapolis, IN; flexible work arrangements.
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