VP, Head of Regulatory in United States at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a VP, Head of Regulatory based in the United States.

This executive leadership role is responsible for shaping and executing global regulatory strategies that enable the advancement of innovative therapeutic programs from early discovery through clinical development. You will lead regulatory interactions with agencies such as the FDA, EMA, and other global health authorities, ensuring alignment across development stages and regulatory expectations. The position plays a critical role in accelerating the path from scientific innovation to patient impact by guiding INDs, CTAs, and other key submissions. You will also build and lead a high-performing regulatory organization spanning strategy, operations, and submissions. This is a highly influential role that combines scientific depth, regulatory expertise, and executive leadership. You will collaborate closely with R&D, clinical, and executive teams in a fast-paced, innovation-driven biotech environment. Your work will directly contribute to advancing first-in-class medicines and transforming drug discovery outcomes.

• Define, lead, and execute global regulatory strategies across early and late-stage development programs, including small molecules and combination products.
• Lead regulatory interactions and negotiations with global health authorities such as the FDA, EMA, and other international agencies.
• Oversee the preparation, authoring, and submission of key regulatory documentation including INDs, CTAs, briefing packages, and regulatory response documents.
• Build, structure, and lead a high-performing regulatory affairs organization covering strategy, operations, and regulatory publishing functions.
• Ensure alignment of regulatory strategies with clinical development, CMC, and broader R&D objectives across programs.
• Provide strategic guidance on regulatory pathways for first-in-class and novel mechanism-of-action therapies.
• Review, refine, and approve regulatory submissions to ensure accuracy, compliance, and strategic positioning.
• Act as the primary regulatory authority representing the organization in external discussions with regulators and partners.
• Monitor evolving global regulatory frameworks and ensure proactive adaptation of strategies and submissions.
• Foster cross-functional collaboration to accelerate development timelines while maintaining compliance and scientific rigor.

• Advanced degree (PhD, PharmD, MSc, or JD) in life sciences, pharmaceutical sciences, or a related regulatory/scientific field.
• 15+ years of progressive experience in global regulatory affairs within biotech, pharmaceutical, or life sciences organizations.
• Proven track record of leading successful regulatory submissions across multiple development stages and global regions.
• Deep expertise in FDA, EMA, and other global regulatory frameworks and submission processes.
• Experience leading regulatory strategy for novel therapeutics, including first-in-class or new mechanisms of action.
• Strong leadership experience building and managing regulatory teams across strategy and operations.
• Excellent communication and negotiation skills with the ability to engage confidently with regulatory agencies and executive stakeholders.
• Strong ability to translate complex scientific and regulatory requirements into clear strategic direction.
• Experience working in fast-paced, innovation-driven biotech or pharma environments.
• High level of strategic thinking, organizational leadership, and cross-functional collaboration skills.

• Annual base salary range of $350,000 – $400,000.
• Comprehensive medical, dental, and vision coverage (approximately 90% employer-covered).
• 401(k) retirement plan with company matching.
• Flexible paid time off policy.
• Adoption assistance benefits.
• Opportunity to lead global regulatory strategy for cutting-edge drug discovery programs.
• Executive-level influence in a high-growth, innovation-driven biotech environment.
• Collaborative culture focused on scientific curiosity, impact, and cross-functional teamwork.