Regulatory Affairs Specialist

Role 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. Requirements 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. Preferred RAC certification. HighValue US FDA regulatory expertise, experience with IND/NDA/BLA submissions, cross‑functional collaboration, lifecycle management, and compliance in an FDA-regulated environment. WorkSetup hybrid in Indianapolis, IN; flexible work arrangements. #J-18808-Ljbffr