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 - 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.