Senior Vice President, Regulatory AffairsMineralys 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.
Key Requirements- 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.
Skills and AttributesAutonomy - 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.
Travel- This position requires up to 20% travel. Frequently travel is outside the local area and overnight.
This position is eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as 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
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