Remote Senior VP, Regulatory Affairs — Global Strategy

Mineralys Therapeutics; United States; Remote; USD 350,000 - 390,000; Full time

Job summary

Mineralys Therapeutics is seeking a Senior Vice President of Regulatory Affairs to lead global regulatory strategy across development and commercial portfolios, owning submissions, agency relationships, and lifecycle compliance.

The role requires guiding cross-functional teams, building a high-performing global Regulatory Affairs function, and ensuring alignment with executive leadership. US remote, travel up to 20%, compensation in the posted range.

Qualifications

• 15+ years of Regulatory Affairs experience in biopharma.
• Experience with NDA submissions and major health authority interactions; MAA experience preferred.
• Proven track record leading regulatory strategy for lifecycle expansion and global launch readiness.
• Experience in a commercial-stage biotechnology or pharmaceutical environment with labeling and post-marketing commitments.
• Mastery of ICH guidelines, FDA and EMA post-marketing regulations, labeling negotiations, and CMC lifecycle requirements.
• Strong cross-functional leadership with Clinical Development, CMC, Quality, Commercial, and Legal.
• Advanced degree preferred: PharmD, PhD, MD, or equivalent.

Responsibilities

• Drive the global regulatory strategy partnering with Clinical Development to shape development plans, trial designs, and endpoints.
• Provide executive oversight for health authority interactions, including labeling and safety changes.
• Oversee global post-approval submissions, including supplemental NDAs and line extensions.
• Build ex-US regulatory approach across priority markets with reliance and joint-review paths.
• Lead commercialization activities and cross-functional alignment with Commercial, Medical Affairs, Quality, and Supply Chain.
• Ensure timely submission of periodic safety/update reports and adherence to post-marketing commitments.
• Act as senior regulatory authority, maintaining relationships with agencies and external advisors.
• Partner with Executive team to align growth objectives, regulatory strategy, and risk management.
• Build and evolve Regulatory Affairs organization and external partnerships to support commercialization.
• Provide strategic and operational guidance to project teams for submissions and compliance.

Skills

Trusted Decision Maker

Self-Directed

Leads from the Front

Regulatory Foresight

Execution under timelines

Ambiguity decision-making

Regulatory Intelligence

Data interpretation

Cross-functional collaboration

Strategic communication

Adaptability

Iterative planning

Education

Advanced degree (PharmD/PhD/MD) or equivalent

Job description

Mineralys Therapeutics is seeking a Senior Vice President of Regulatory Affairs to lead global regulatory strategy across development and commercial portfolios, owning submissions, agency relationships, and lifecycle compliance.

The role requires guiding cross-functional teams, building a high-performing global Regulatory Affairs function, and ensuring alignment with executive leadership. US remote, travel up to 20%, compensation in the posted range.