Vice President, Regulatory Affairs

This is a fully remote position, open to applicants in Virginia.

📋 Description

• Create and implement cutting-edge regulatory strategies that enhance development efficiency and boost the likelihood of approval.

• Act as the main regulatory liaison with the FDA and other global health authorities for Contraline.

• Oversee all regulatory facets of product development from preclinical phases to commercialization.

• Offer strategic insights as needed for corporate planning, fundraising efforts, business development initiatives, and communications with investors.

• Engage in non-promotional and promotional reviews as the Regulatory Affairs representative.

• Develop and expand the regulatory affairs function as the company evolves.

• Lead the preparation for meetings with regulatory agencies, including Pre-IND, Type B, End-of-Phase 2, and Pre-NDA/BLA discussions.

• Manage the preparation and submission of INDs, NDAs, BLAs, amendments, and international regulatory applications.

• Provide regulatory guidance for drug-drug and drug-device combination products.

• Collaborate closely with Clinical Development, CMC, Quality, Nonclinical, Medical Affairs, and external collaborators.

• Assess emerging regulatory risks and opportunities, offering proactive mitigation strategies.

• Assist in due diligence activities related to partnerships, licensing prospects, and acquisitions.

⛳️ Requirements

• Advanced scientific degree (PhD, PharmD, MD, MS, or equivalent) in a relevant field and/or Regulatory Affairs Certification (RAC).

• At least 15 years of regulatory affairs experience in pharmaceutical and/or biotechnology sectors.

• Extensive experience leading interactions with the FDA and major regulatory submissions, including familiarity with 505(b)(2) submissions.

• Proven track record of securing IND clearances and progressing development programs through critical regulatory milestones.

• Experience in formulating regulatory strategies for innovative therapeutic products.

• Comprehensive understanding of clinical development, CMC, nonclinical development, and commercialization needs.

• Established ability to function efficiently in entrepreneurial, resource-limited environments.

🏝️ Benefits

• Applicants must have authorization to work in the United States.

• Committed to fostering a diverse, inclusive, and genuine workplace.