About the role
Vice President, Regulatory Affairs Vice President, Regulatory Affairs About Contraline Inc. Contraline is a clinical-stage biotechnology company focused on innovation in male reproductive health. The company is advancing both hormonal and non-hormonal approaches to expand contraceptive options for men and couples globally. Following its recently completed Series B financing, Contraline is entering a pivotal stage of growth as it advances toward late-stage clinical development, regulatory milestones, expanded manufacturing, and future product launch.
About
the role The Vice President, Regulatory Affairs will serve as Contraline’s senior regulatory leader and strategic advisor, responsible for developing and executing global regulatory strategies across a growing pipeline of innovative therapeutics and devices. Reporting directly to the Chief Scientific Officer, this individual will play a critical role in shaping development plans, regulatory pathways, corporate strategy, and investor-facing communications. This hands-on leader will thrive in a fast-paced biotechnology environment and possess a demonstrated ability to leverage existing regulatory resources and build regulatory capabilities from the ground up. The successful candidate will have extensive experience interacting with FDA and other global health authorities and will provide regulatory leadership for complex development programs, including drug-drug combination products and drug-device combination products. Key
Responsibilities Develop and execute innovative regulatory strategies that maximize development efficiency and increase probability of approval. Serve as the primary regulatory contact with FDA for Contraline and other health authorities worldwide. Lead all regulatory aspects of product development from preclinical stages through commercialization. Provide strategic input when required into corporate planning, fundraising activities, business development transactions, and investor communications. Participate in nonpromotional and promotional review as the Regulatory Affairs representative. Build and scale the regulatory affairs function as the organization grows. Lead preparation for regulatory agency meetings including Pre-IND, Type B, End-of-Phase 2, and Pre-NDA/BLA interactions. Oversee preparation and submission of INDs, NDAs, BLAs, amendments, and global regulatory applications. Provide regulatory leadership for drug-drug combination products and drug-device combination products. Collaborate closely with Clinical Development, CMC, Quality, Nonclinical, Medical Affairs, and external partners. Evaluate emerging regulatory risks and opportunities and provide proactive mitigation strategies. Support diligence activities related to partnerships, licensing opportunities, and acquisitions. Required
