Senior Vice President, Regulatory Affairs New Remote, US
Senior Vice President, Regulatory Affairs Remote, US Mineralys Therapeutics is a publicly traded, clinical-stage biotechnology company focused on developing medicines to target diseases driven by abnormally elevated aldosterone. Our initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that we are developing for cardiorenal conditions affected by abnormally elevated aldosterone, including hypertension and chronic kidney disease. The Senior Vice President, Regulatory Affairs reports to the Chief Medical Officer and is responsible for leading Mineralys’ global regulatory function. This individual will play a critical role in shaping and driving successful regulatory outcomes, with particular focus on New Drug Application (NDA) submissions, interactions with regulatory authorities, development-stage and post-approval strategy. Prior experience working at the U.S. Food and Drug Administration (FDA) is strongly preferred and will provide valuable insight into agency expectations and communications. Develop and own the global regulatory strategy through NDA submission and approval. Lead the preparation, submission, and lifecycle management of major regulatory filings. Serve as the primary regulatory voice in cross-functional teams, aligning clinical, CMC, commercial and nonclinical strategies with regulatory expectations. Serve as primary regulatory contact for FDA and other health authorities; lead the planning and execution of regulatory interactions (e.g., Type B and Type C meetings, pre-NDA meetings). Provide expert regulatory input into protocols, study reports, and other key submission documents. Support strategic risk assessments and scenario planning related to regulatory pathways and clinical development. Build and maintain productive relationships with regulatory agencies and external advisors. Provide strategic and operational input, guidance, and oversight to project teams to assure that regulatory submissions and all aspects of regulatory compliance support corporate objectives. Skills and Attributes Velocity – Drive Speed with Purpose Regulatory Foresight & Acceleration with urgency Execution Under Tight Timelines Manage complex regulatory submissions on compressed schedules without compromising quality. Mobilize teams quickly around high-priority milestones and deadlines. Clear Decision-Making in Ambiguity Move forward with confidence, offering informed paths that balance risk and speed. Data-Driven Decision Making – Ground Strategy in Evidence Regulatory Intelligence & Precedent-Based Reasoning Leverage regulatory precedents, precedent filings, and agency decisions to craft compelling, data-backed strategies. Clinical & CMC Data Interpretation Partner closely with cross functional teams to frame data in a way that is scientifically rigorous Metrics-Oriented Define and track regulatory success indicators (e.g., meeting outcomes, submission timelines, response quality). Agile Mindset – Embrace Iteration and Change Adaptability to Shifting Development Plans Quickly pivot strategy in response to new clinical data, CMC changes, or regulatory feedback. Iterative Planning & Engagement Design flexible submission plans and health authority engagement strategies that evolve with program needs. Frictionless Execution – Simplify the Path to Results Operational Clarity & Precision Streamline regulatory workflows and documentation processes to minimize rework and improve speed of delivery. Lean, Cross-Functional Collaboration Coordinate seamlessly with other functions to reduce bottlenecks, clarify responsibilities, and keep execution smooth. Strategic Communication Communicate clearly, with minimal noise, from executive summaries to health authority meeting packages. Autonomy – Lead with Ownership and Accountability Self-Directed and Proactive Identify risks and opportunities independently and bring forward solutions without waiting for instruction. Trusted Decision Maker Serve as the regulatory authority internally by confidently guiding teams and executives on critical go/no-go and submission decisions. Leads from the Front Model high standards, integrity, quality and accountability acting as a trusted external company representative with regulators and internally at the leadership table. Education and Experience Advanced degree preferred: PharmD, PhD, MD, or equivalent in a scientific or healthcare discipline. 12+ years of progressively responsible experience in Regulatory Affairs within the biopharmaceutical industry, including significant experience leading regulatory strategy. Proven track record of successful NDA submissions and interactions with the FDA and other health authorities. Preferred: Prior experience working at the FDA (e.g., CDER, CBER), offering direct insight into agency expectations and internal processes. Experience spanning the full product lifecycle—from early development through approval a