Hiring: Vice President, Regulatory Affairs Company: Hinge Bio Location: Redwood City, CA Job Posted Time: 2026-09-16 23:23:45 About the job Experience: •Minimum 15 years of biotechnology, pharmaceutical, or regulatory affairs experience. •At least 8 years in positions of increasing leadership responsibility. •Demonstrated success leading global regulatory strategy for biologics. •Direct, hands-on experience with IND preparation, drafting and maintenance. •Prior experience within a small or emerging biotechnology company strongly preferred. Required Skills: •As a member of the senior leadership team, the VP will provide strategic regulatory input to corporate planning, business development evaluations, investor communications, and long-range portfolio strategy. •Regulatory Strategy & Leadership •Develop and execute global regulatory strategies for biologics from preclinical development through clinical proof-of-concept. •Lead regulatory planning and risk assessment for development programs, ensuring alignment with corporate objectives and development timelines. •Provide strategic guidance regarding regulatory requirements, expedited development pathways, orphan designation opportunities, and interactions with health authorities. •Build and lead a scalable regulatory function appropriate for a growing biotechnology company. •Lead preparation for and participation in FDA meetings, including Pre-IND, INTERACT, Type B, End-of-Phase, and other regulatory interactions. •Develop briefing documents, meeting strategies, and responses to agency feedback. Qualifications: •Advanced degree in life sciences, pharmacy, medicine, public health, or related field preferred. •PhD, PharmD, MD, or MS strongly preferred. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!