Senior Vice President, Head of Global Regulatory Affairs

Accountabilities

- Develop and execute U.S. and global regulatory strategies aligned with business objectives and the evolving product pipeline.

- Provide regulatory direction and expert guidance to development teams and senior leadership, including strategic advice on regulatory risks and opportunities.

- Lead global regulatory strategy across late-stage development, launch readiness, product registration, and post-approval lifecycle management.

- Oversee regulatory activities related to CMC, preclinical development, clinical development, commercialization, labeling, renewals, supplements, variations, and post-marketing commitments.

- Serve as the primary day-to-day liaison with regulatory authorities, leading meeting requests, briefing materials, agency interactions, and responses to regulatory information requests.

- Represent Regulatory Affairs on cross-functional development teams and contribute strategically to clinical development plans.

- Lead, develop, and scale the regulatory organization, identifying talent-development opportunities and anticipating future capabilities required by the pipeline.

- Establish, maintain, and implement regulatory policies, standards, procedures, and operating practices.

- Ensure regulatory operations comply with applicable FDA, EU, ICH, EMA, and other relevant regulatory requirements and industry standards.

- Partner with Commercial, Medical Affairs, Legal and Compliance, Quality, Pharmacovigilance, Supply Chain, and Market Access teams to support launch readiness, compliant communications, global labeling, and lifecycle planning.

- Oversee regulatory timelines, deliverables, and submission activities, including electronic submission processes and preparation of regulatory documentation.

- Review, author, or edit regulatory and clinical documents as required, including investigator materials, study documentation, informed consents, presentations, and reports.

- Identify and engage regulatory experts and external consultants as appropriate to support strategic and operational objectives.

- Support European regulatory and distribution requirements, including coordination with the designated EU representative responsible for applicable Good Distribution Practice requirements.

Requirements

- Advanced degree preferred, with extensive experience in pharmaceutical or biotechnology regulatory affairs.

- 15+ years of regulatory experience, including at least 10 years in senior leadership roles.

- Demonstrated experience developing and executing regulatory strategies for late-stage, launch, and commercial-stage products across U.S. and international markets.

- Strong knowledge of the drug development lifecycle and regulatory environments across the United States, European Union, and other global regions.

- Proven experience with post-approval regulatory activities, including labeling strategies, safety updates, CMC changes, post-marketing commitments, renewals, supplements, and variations.

- Experience leading and developing regulatory professionals and managing external regulatory partners, ideally within an organization undergoing significant growth or expansion.

- Advanced ability to interpret regulations, regulatory guidelines, precedents, and requirements relevant to pharmaceutical development and commercialization.

- Demonstrated ability to advise executive and commercial leadership on regulatory considerations affecting launch timing, market access, labeling, promotional strategy, competitive positioning, and lifecycle management.

- Strong understanding of regulatory submissions and electronic submission processes, with the ability to guide cross-functional teams through submission preparation.

- Excellent strategic leadership, judgment, and decision-making skills, with the ability to simplify complex regulatory issues and establish clear direction.

- Strong project and timeline management skills, including the ability to accurately forecast regulatory milestones and manage competing deliverables.

- Excellent written, verbal, listening, and interpersonal communication skills, with a collaborative approach to cross-functional leadership.

- Ability to build strong relationships with regulatory authorities, internal stakeholders, consultants, and external partners.

- Ability to work effectively in a remote environment and travel as required by business needs.

Benefits

- Competitive base salary.

- Annual performance bonus opportunity.

- Long-term incentive program.

- Health insurance coverage.

- Dental and vision insurance.

- Term life insurance.

- Disability coverage.

- Retirement plans.

- Remote work arrangement within the United States.

- Travel opportunities as required to support business and regulatory activities.

- Opportunity to lead global regulatory strategy across development, commercialization, and product lifecycle management.

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