Vice President, Regulatory Affairs

Contraline, Inc.; Charlottesville (VA); On-site; USD 210,000 - 320,000; Full time

Job summary

Contraline, Inc. is seeking a senior regulatory leader to develop and execute global regulatory strategies across its growing pipeline of therapeutics and devices, guiding INDs, NDAs, and regulatory submissions in collaboration with cross-functional teams.

The role requires an advanced scientific degree and 15+ years of regulatory affairs experience, with demonstrated FDA interactions and major submissions.

Qualifications

• 15+ years of regulatory affairs experience in pharma/biotech
• Experience leading FDA interactions and major submissions (including 505(b)(2))
• Proven success obtaining IND clearances and advancing programs
• Ability to operate in entrepreneurial, resource-constrained environments

Responsibilities

• Develop and execute global regulatory strategies
• Lead regulatory interactions with FDA and other authorities
• Oversee preparation and submission of INDs, NDAs, BLAs, and global filings
• Build and scale the regulatory affairs function as the company grows
• Collaborate with Clinical Development, CMC, Quality, Nonclinical, Medical Affairs, and external partners
• Evaluate regulatory risks and mitigate proactively
• Support diligence activities related to partnerships and acquisitions

Skills

Regulatory leadership

FDA interactions

Regulatory strategy

Cross-functional collaboration

Stakeholder management

Education

PhD/MD/PharmD (relevant field)

Regulatory Affairs Certification (RAC)

Job description

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.

Serve as Contraline’s senior regulatory leader, responsible for developing and executing global regulatory strategies across a growing pipeline of innovative therapeutics and devices.

What you’ll do

• 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.

What you’ll need

• 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

Contraline’s products are investigational and have not been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority.