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.