Senior Vice President, Regulatory Affairs New Remote, US

Senior Vice President, Regulatory Affairs Remote, US reputed company is a publicly traded, clinical-stage biotechnology company reputed company on developing medicines to reputed company 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 reputed company, with particular reputed company on New Drug Application (NDA) submissions, interactions with regulatory authorities, development-stage and post-approval reputed company. Prior experience working at the U.S. Food and Drug Administration (FDA) is strongly preferred and will reputed company valuable reputed company into agency expectations and communications. reputed company and own the global regulatory reputed company through NDA submission and approval. reputed company the preparation, submission, and lifecycle management of major regulatory filings. Serve as the primary regulatory voice in cross-functional teams, aligning clinical, CMC, reputed company and nonclinical strategies with regulatory expectations. Serve as primary regulatory contact for FDA and other health authorities; reputed company the planning and execution of regulatory interactions (e.g., Type B and Type C meetings, reputed company-NDA meetings). reputed company expert regulatory input into protocols, study reports, and other key submission documents. Support strategic risk assessments and scenario planning reputed company to regulatory reputed company and clinical development. Build and maintain productive relationships with regulatory agencies and external advisors. reputed company strategic and operational input, guidance, and reputed company to project teams to assure that regulatory submissions and reputed company 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 reputed company regulatory submissions on compressed schedules without compromising reputed company. Mobilize teams quickly around high-reputed company milestones and deadlines. reputed company Decision-Making in Ambiguity reputed company reputed company with confidence, offering informed paths that balance risk and speed. Data-Driven Decision Making – Ground reputed company in Evidence Regulatory Intelligence & Precedent-Based Reasoning reputed company regulatory precedents, precedent filings, and agency reputed company to craft compelling, data-backed strategies. Clinical & CMC Data Interpretation Partner closely with cross functional teams to reputed company data in a way that is scientifically rigorous Metrics-Oriented Define and reputed company regulatory reputed company indicators (e.g., meeting reputed company, submission timelines, response reputed company). Agile reputed company – reputed company Iteration and Change Adaptability to Shifting Development Plans Quickly pivot reputed company in response to new clinical data, CMC changes, or regulatory feedback. Iterative Planning & Engagement Design flexible submission plans and health authority engagement strategies that reputed company with program needs. Frictionless Execution – Simplify the reputed company to Results Operational reputed company & 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 reputed company execution smooth. Strategic Communication Communicate reputed company, with minimal noise, from executive summaries to health authority meeting packages. Autonomy – reputed company with Ownership and Accountability Self-Directed and Proactive Identify risks and opportunities independently and bring reputed company solutions without waiting for instruction. Trusted Decision reputed company Serve as the regulatory authority internally by confidently guiding teams and executives on critical go/no-go and submission reputed company. Leads from the reputed company Model high standards, reputed company, reputed company 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 reputed company discipline. 12+ years of progressively responsible experience in Regulatory Affairs reputed company the biopharmaceutical industry, including significant experience leading regulatory reputed company. Proven reputed company 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 reputed company reputed company into agency expectations and internal processes. Experience spanning the full product lifecycle—from early development through approval a Apply tot his job Apply To this Job Apply To This Job Apply To This Job