Senior Vice President, Head of Global Regulatory Affairs
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Vice President, Head of Global Regulatory Affairs based in United States.
This is a senior executive role responsible for shaping and executing global regulatory strategy across the full drug development lifecycle.
You will lead regulatory strategy spanning CMC, preclinical, clinical development, commercialization, and post-approval activities across multiple regions.
The role serves as a key advisor to senior leadership, providing guidance on regulatory risk, development strategy, launch timing, and lifecycle management.
You will lead a regulatory organization while partnering closely with clinical, commercial, medical, legal, quality, safety, supply chain, and market access teams.
The position combines strategic leadership with hands-on oversight of submissions, health authority interactions, regulatory operations, and compliance.
You will help prepare products for late-stage development, global registration, launch, and ongoing commercialization.
This is a remote U.S.-based position with travel as needed to support business and regulatory requirements.
Accountabilities
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Develop and execute U.S. and global regulatory strategies aligned with business objectives and the evolving product pipeline.
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Provide regulatory direction and expert guidance to development teams and senior leadership, including strategic advice on regulatory risks and opportunities.
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Lead global regulatory strategy across late-stage development, launch readiness, product registration, and post-approval lifecycle management.
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Oversee regulatory activities related to CMC, preclinical development, clinical development, commercialization, labeling, renewals, supplements, variations, and post-marketing commitments.
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Serve as the primary day-to-day liaison with regulatory authorities, leading meeting requests, briefing materials, agency interactions, and responses to regulatory information requests.
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Represent Regulatory Affairs on cross-functional development teams and contribute strategically to clinical development plans.
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Lead, develop, and scale the regulatory organization, identifying talent-development opportunities and anticipating future capabilities required by the pipeline.
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Establish, maintain, and implement regulatory policies, standards, procedures, and operating practices.
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Ensure regulatory operations comply with applicable FDA, EU, ICH, EMA, and other relevant regulatory requirements and industry standards.
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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.
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Oversee regulatory timelines, deliverables, and submission activities, including electronic submission processes and preparation of regulatory documentation.
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Review, author, or edit regulatory and clinical documents as required, including investigator materials, study documentation, informed consents, presentations, and reports.
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Identify and engage regulatory experts and external consultants as appropriate to support strategic and operational objectives.
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Support European regulatory and distribution requirements, including coordination with the designated EU representative responsible for applicable Good Distribution Practice requirements.
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Advanced degree preferred, with extensive experience in pharmaceutical or biotechnology regulatory affairs.
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15+ years of regulatory experience, including at least 10 years in senior leadership roles.
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Demonstrated experience developing and executing regulatory strategies for late-stage, launch, and commercial-stage products across U.S. and international markets.
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Strong knowledge of the drug development lifecycle and regulatory environments across the United States, European Union, and other global regions.
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Proven experience with post-approval regulatory activities, including labeling strategies, safety updates, CMC changes, post-marketing commitments, renewals, supplements, and variations.
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Experience leading and developing regulatory professionals and managing external regulatory partners, ideally within an organization undergoing significant growth or expansion.
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Advanced ability to interpret regulations, regulatory guidelines, precedents, and requirements relevant to pharmaceutical development and commercialization.
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Demonstrated ability to advise executive and commercial leadership on regulatory considerations affecting launch timing, market access, labeling, promotional strategy, competitive positioning, and lifecycle management.
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Strong understanding of regulatory submissions and electronic submission processes, with the ability to guide cross-functional teams through submission preparation.
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Excellent strategic leadership, judgment, and decision-making skills, with the ability to simplify complex regulatory issues and establish clear direction.
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Strong project and timeline management skills, including the ability to accurately forecast regulatory milestones and manage competing deliverables.
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Excellent written, verbal, listening, and interpersonal communication skills, with a collaborative approach to cross-functional leadership.
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Ability to build strong relationships with regulatory authorities, internal stakeholders, consultants, and external partners.
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Ability to work effectively in a remote environment and travel as required by business needs.
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Competitive base salary.
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Annual performance bonus opportunity.
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Long-term incentive program.
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Health insurance coverage.
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Dental and vision insurance.
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Term life insurance.
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Disability coverage.
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Retirement plans.
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Remote work arrangement within the United States.
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Travel opportunities as required to support business and regulatory activities.
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Opportunity to lead global regulatory strategy across development, commercialization, and product lifecycle management.