Vice President, Regulatory Affairs

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.

Benefits

• Comprehensive benefits package including medical, dental, vision, and 401(k) with company contributions.
• Shared ownership opportunity through participation in the Company’s equity incentive program.

Application Information

• Applicants must be authorized to work in the United States.

About Contraline Inc.

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.