Regulatory Affairs Manager

Regulatory Affairs Manager (contractor) responsible for supporting the development of regulatory submission strategy and health authority interactions for assigned clinical studies, as well as reviewing regulatory documents and applications under the guidance of the Regulatory Affairs Lead, in accordance with applicable global regulations and guidelines. The contractor will collaborate effectively with cross-functional teams, external partners, vendors, and stakeholders while contributing to a positive and collaborative team environment. Duration: 6–12 months, with potential for extension. Hybrid: Onsite 2-3 days/week in South San Francisco Position Responsibilities Support preparation of responses to health authority questions and information requests Review regulatory documents including, but not limited to, Protocols, Investigator’s Brochures, Development Safety Update Reports, and clinical trial applications Participate actively in global regulatory project teams and clinical strategy discussions Collaborate closely with the Regulatory Affairs Lead and cross-functional stakeholders to support ongoing regulatory activities across the development pipeline Maintain and share regulatory intelligence and relevant updates within the function Perform periodic updates in regulatory information management systems and associated archives (e.g., several times per year) Support review and assessment of regulatory SOPs as needed Ensure regulatory submission tracking tools are kept current, including documentation of planned and delayed submissions Maintain regulatory archives and health authority tracking records, including ongoing updates for multiple active clinical programs and associated global communications Support coordination with external partners to ensure completeness of regulatory documentation archives Position Requirements Bachelor’s degree in a life science discipline from an accredited institution; advanced degree (MS, PharmD, or PhD) preferred Minimum of 5 years of regulatory affairs experience in a pharmaceutical, biotechnology, or clinical research organization environment Experience working with regulatory information management systems (e.g., Veeva Vault or equivalent platforms) Working knowledge of global regulatory requirements (e.g., ICH guidelines, FDA, EMA) Strong organizational skills with a focus on high-quality deliverables Ability to manage multiple projects with tight timelines Strong interpersonal skills and ability to build effective cross‑functional relationships Detail‑oriented with excellent written and verbal communication skills Self‑directed and collaborative working style Comfortable operating in a fast‑paced, evolving environment with a proactive, hands‑on approach #J-18808-Ljbffr Meet Life Sciences