[Hiring] Senior Vice President of Regulatory Affairs @Mineralys Therapeutics

Role Description

Mineralys is seeking an accomplished, strategic Senior Vice President of Regulatory Affairs to lead global regulatory strategy across our development and commercial portfolio and serve as a key member of the Leadership Team. This leader owns the regulatory function end-to-end; shaping submission strategy, maintaining agency relationships, and ensuring compliance across all stages of the product lifecycle.

Principal Responsibilities

• Drive the global regulatory strategy partnering with Clinical Development to shape development plans, trial designs, and endpoints.
• Provide executive oversight and strategic direction for health authority interactions, including product labeling and safety changes.
• Oversee global post-approval submissions, including supplemental NDAs, line extensions, manufacturing variations, and renewals.
• Build the ex-US regulatory approach across priority markets, applying reliance and joint-review pathways where they accelerate global development plans.
• Lead commercialization activities and cross-functional alignment across departments including Commercial, Medical Affairs, Quality, and Supply Chain.
• Ensure timely submission of periodic safety update reports and annual reports, and compliance with global post-marketing commitments.
• Serve as the senior regulatory authority for the company, building and maintaining productive relationships with regulatory agencies and external advisors.
• Partner with the Executive team and cross-functional leaders across Clinical Development, Commercial, Quality, CMC, and Legal to align growth objectives, regulatory strategy, and risk management.
• Build, lead, and develop a high-performing global Regulatory Affairs function with clear accountability, strong succession, and fit-for-purpose capabilities.
• Build and evolve the Regulatory Affairs organization, capabilities, processes, and external partnerships needed to support Mineralys through commercialization and the company’s continued growth.
• Provide strategic and operational guidance to project teams to ensure regulatory submissions and compliance activities support corporate objectives.

Qualifications

• 15+ years of progressively responsible Regulatory Affairs experience in the biopharmaceutical industry, including significant experience leading regulatory strategy and teams.
• Successful experience with NDA submissions and major health authority interactions; MAA experience strongly preferred.
• Experience with small molecules and cardiometabolic diseases is preferred.
• Proven track record leading regulatory strategy for lifecycle expansion, working closely with Clinical Development on programs, expedited pathways, and global launch readiness.
• Experience in a commercial-stage biotechnology or pharmaceutical environment, with strong knowledge of regulatory requirements for 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, particularly with Clinical Development, CMC, Quality, Commercial, and Legal teams.
• Proven track record of building and mentoring high-performing regulatory teams and influencing executive strategy.
• Advanced degree preferred, including PharmD, PhD, MD, or equivalent in a scientific or healthcare discipline.

Requirements

• Autonomy - Lead with Ownership and Accountability.
• Trusted Decision Maker - Serve as the senior regulatory authority internally, confidently guiding teams and executives on critical development, go or no-go, submission, and labeling decisions.
• Self-Directed and Proactive - Identify risks and opportunities early and bring forward clear recommendations without waiting for instruction.
• Leads from the Front - Model high standards, integrity, quality, and accountability as a trusted company representative with regulators and at the leadership table.
• Velocity - Drive Speed with Purpose.
• Regulatory Foresight and Acceleration - Anticipate regulatory risks and opportunities and translate them into strategies that accelerate sound decisions and execution.
• Execution Under Tight Timelines - Manage complex regulatory submissions on compressed schedules without compromising quality. Mobilize teams quickly around priority milestones and deadlines.
• Clear Decision-Making in Ambiguity - Move forward with confidence, offering informed paths that balance risk, quality, and speed.
• Data-Driven Decision Making - Ground Strategy in Evidence.
• Regulatory Intelligence and Precedent-Based Reasoning - Use regulatory precedents, relevant filings, and agency decisions to craft compelling, evidence-based strategies.
• Clinical and CMC Data Interpretation - Partner closely with cross-functional teams to frame data in a scientifically rigorous and regulator-ready manner.
• Metrics-Oriented - Define and track meaningful regulatory success indicators, including meeting outcomes, submission timelines, and response quality.
• Frictionless Execution - Simplify the Path to Results.
• Operational Clarity and Precision - Streamline regulatory workflows and documentation to minimize rework and improve speed of delivery.
• Cross-Functional Collaboration - Coordinate seamlessly across functions to reduce bottlenecks, clarify responsibilities, and maintain momentum.
• Strategic Communication - Communicate clearly and concisely, from executive recommendations to health authority meeting packages.
• Agile Mindset - Embrace Iteration and Change.
• Adaptability to Shifting Development Plans - Adjust strategy quickly in response to new clinical data, CMC changes, or regulatory feedback.
• Iterative Planning and Engagement - Design flexible submission plans and health authority engagement strategies that evolve with program needs.

Benefits

• This position is eligible for standard Company benefits including medical, dental, vision, time off, and 401K.
• Participating in Mineralys incentive plans are contingent on achievement of personal and company performance.
• Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level.
• US Salary Range: $350,000 - $390,000.

Travel

This position requires up to 20% travel. Frequently travel is outside the local area and overnight.