Vice President, Regulatory Affairs
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Job Description
Vice President of Regulatory Affairs developing global strategies for innovative therapeutics and devices at Contraline. Leading regulatory processes from preclinical stages to commercialization as a senior regulatory leader.
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.
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.
Benefits:
- Applicants must be authorized to work in the United States
- Dedicated to building a diverse, inclusive and authentic workplace
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