Senior Vice President, Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead the global regulatory strategy by collaborating with Clinical Development to refine development plans, trial designs, and endpoints.

• Provide executive leadership and strategic direction for interactions with health authorities, including product labeling and safety modifications.

• Supervise global post-approval submissions, such as supplemental NDAs, line extensions, manufacturing variations, and renewals.

• Develop the regulatory approach for markets outside the U.S., utilizing reliance and joint-review pathways as appropriate.

• Direct commercialization efforts and ensure cross-functional alignment among Commercial, Medical Affairs, Quality, and Supply Chain teams.

• Guarantee timely submission of periodic safety update reports and annual reports, while ensuring compliance with global post-marketing obligations.

• Act as the senior regulatory authority, fostering productive relationships with regulatory agencies and external advisors.

• Collaborate with the Executive team and cross-functional leaders in Clinical Development, Commercial, Quality, CMC, and Legal departments.

• Establish, lead, and nurture a high-performing global Regulatory Affairs function.

• Enhance the Regulatory Affairs organization, capabilities, processes, and external partnerships.

• Offer strategic and operational guidance to project teams regarding regulatory submissions and compliance activities.

⛳️ Requirements

• Over 15 years of progressively responsible experience in Regulatory Affairs within the biopharmaceutical sector, including substantial experience in leading regulatory strategy and teams.

• Proven success with NDA submissions and significant interactions with major health authorities.

• Preferred experience with small molecules and cardiometabolic diseases.

• Demonstrated history of leading regulatory strategy for lifecycle expansion, closely collaborating with Clinical Development on programs, expedited pathways, and global launch readiness.

• Experience in a fully commercial-stage biotechnology or pharmaceutical setting.

• In-depth knowledge of regulatory requirements concerning product labeling, promotional review, and post-marketing commitments.

• Mastery of ICH guidelines, FDA and EMA post-marketing regulations, labeling negotiations, and CMC lifecycle requirements.

• Strong cross-functional leadership experience with Clinical Development, CMC, Quality, Commercial, and Legal teams.

• Proven ability to build and mentor high-performing regulatory teams while influencing executive strategy.

• Advanced degree preferred, such as PharmD, PhD, MD, or an equivalent in a scientific or healthcare discipline.

• Willingness to travel up to 20%, often outside the local area and requiring overnight stays.

🏝️ Benefits

• Medical insurance

• Dental insurance

• Vision insurance

• Time off

• 401K

• Participation in Mineralys incentive plans contingent on the achievement of personal and company performance

• Fully remote work arrangement