Senior Vice President, Regulatory Affairs

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

📋 Description

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

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

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

• Develop the regulatory approach for markets outside the US, implementing reliance and joint-review pathways where suitable.

• 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, ensuring compliance with global post-marketing commitments.

• Act as the primary regulatory authority while fostering productive relationships with regulatory agencies and external advisors.

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

• Build, lead, and cultivate a high-performing global Regulatory Affairs team.

• Develop and enhance the Regulatory Affairs organization, its 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 significant leadership in regulatory strategy and team management.

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

• Preference for experience with small molecules and cardiometabolic diseases.

• Demonstrated ability to lead regulatory strategy for lifecycle expansion, closely collaborating with Clinical Development on programs, expedited pathways, and global launch readiness.

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

• Strong understanding of regulatory requirements related to product labeling, promotional review, and post-marketing commitments.

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

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

• Proven history of building and mentoring high-performing regulatory teams and influencing executive strategy.

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

• 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

• Eligibility for participation in Mineralys incentive plans based on personal and company performance achievements

• Fully remote work arrangement