Manager, Regulatory Affairs

Role: Regulatory Affairs Specialist supporting global regulatory projects at a biopharma focused on RNAi therapeutics for genetic diseases. Responsibilities: lead regulatory filing preparations (IND, CTA, reports), develop and execute regulatory strategies aligned with product development and commercialization goals, coordinate with global/regional teams for submissions, monitor timelines, ensure compliance, communicate regulatory updates, review technical documentation, and integrate regulatory intelligence into project plans. Requirements: Bachelor's or Master’s degree with 5+ years or PharmD/PhD with 3+ years of regulatory experience; deep knowledge of FDA and international regulations; strong project management, communication, and collaboration skills; experience in fast-paced, entrepreneurial settings. HighValue: experience with INDs, CTAs, global regulatory submissions, biotech or gene therapy product development; familiarity with GxP, technical documentation review, and cross-functional team interaction. WorkSetup: not specified; candidate must be authorized to work in the U.S.