Senior Vice President, Head of Global Regulatory Affairs in New York 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 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.

• 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.

• 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.

• 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.