Vice President, Regulatory Affairs
About The Position
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.
Requirements
- Advanced scientific degree (PhD, PharmD, MD, MS, or equivalent) in a relevant discipline and/or Regulatory Affairs Certification (RAC).
- Minimum 15 years of regulatory affairs experience in pharmaceutical and/or biotechnology companies.
- Significant experience leading FDA interactions and major regulatory submissions including experience with 505(b)(2) submissions.
- Demonstrated success obtaining IND clearances and advancing development programs through key regulatory milestones.
- Experience developing regulatory strategies for innovative therapeutic products.
- Strong understanding of clinical development, CMC, nonclinical development, and commercialization requirements.
- Proven ability to operate effectively in entrepreneurial, resource-constrained environments.
- Exceptional leadership, communication, and stakeholder management skills.
Nice To Haves
- Global regulatory affairs experience supporting EMA, MHRA, PMDA, Health Canada, TGA, and other international regulatory authorities.
- Experience with medical device strategies and submissions (i.e. 510(k), 510(k) De Novo and PMAs).
- Experience with breakthrough therapy, fast track, accelerated approval, RMAT, or orphan drug programs.
- Experience supporting drug-device combination products and human factors programs.
- Prior experience in venture-backed biotechnology companies.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
