About the roleThe 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 Qualifications- 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
Preferred Qualifications- 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.
Leadership Characteristics- Entrepreneurial mindset with a willingness to be both strategic and operational.
- Ability to make decisions with incomplete information while balancing risk and opportunity.
- Executive presence and ability to engage effectively with Boards of Directors, investors, and external stakeholders.
- Collaborative leader who can build high-performing teams and influence across functions.
- Passion for innovation and advancing therapies that improve patient outcomes.
Success Measures- Achievement of key regulatory milestones aligned with corporate objectives.
- Successful regulatory interactions resulting in clear development pathways.
- Development of scalable regulatory capabilities that support company growth.
Applicants must be authorized to work in the United States.
Contraline is a Charlottesville-based company working at the forefront of reproductive medicine. We believe that we go further when we go together. We are dedicated to building a diverse, inclusive and authentic workplace. If you're excited about this role but your past experience doesn't align perfectly with every qualification in the job description, we encourage you to apply anyways. All backgrounds, identities, and voices are welcomed!
The pay range for this role is:
200,000 - 275,000 USD per year (Remote (United States))
