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.