Vice President, Regulatory Affairs

Vice President, Regulatory Affairs Posting – April 2026 The Vice President, Regulatory Affairs brings broad experience in oncology and non-oncology regulatory affairs and operations along with a roll up the sleeves approach to establish and grow an in-house regulatory function. This role will drive the successful development of an innovative pipeline of novel small molecule oncology targeted therapies.  Job Responsibilities: Lead the Regulatory (Regulatory affairs and operations) function enabling measured growth and evolution from a primarily outsourced model as the company and pipeline grows Optimize CRO interactions and lead external regulatory CROs and vendors to drive excellence and meet phase appropriate regulations and timelines Develop and manage Regulatory budgets Develop plans for growth of the regulatory function and hire, manage, and develop Regulatory personnel Develop and implement regulatory strategy across a growing pipeline of early- and mid-stage development programs, with a focus on the successful registration of these products  Enable creative solutions to regulatory challenges to efficiently advance novel cancer therapeutics to key development milestones including positioning for successful pivotal trials and registration Ensure effective risk management and communication of issues/risks across the portfolio, and participate in driving prioritization of resource and spend Plan, oversee and participate in all regulatory activities, including regulatory submissions (INDs, NDAs, MAAs, CTAs etc), preparation and leading of agency meetings Serve as the company contact with the FDA and other regulatory authorities Provide direction and oversight to internal teams and consultants, to ensure the compliance of R&D activities with U.S. and international requirements Partner cross-functionally with Clinical, CMC and Nonclinical teams to ensure alignment of regulatory strategy with overall program and corporate objectives Contribute to corporate and portfolio-level planning, including development prioritization, scenario planning, and long-range regulatory strategy  Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations Preferred Experience and Qualifications: Bachelor’s or more advanced degree in a scientific discipline 15+ years of regulatory experience in the pharmaceutical or biotech industry. Experience in leading decision-making and working in small biotech environment is highly preferred Oncology and non-oncology drug development experience required with a track record of successful regulatory filings, leading regulatory authority interactions and NDA filings Experience in rare disease development, including expedited pathways and regulatory designations, is a plus Expert knowledge of US drug development regulations Experience and knowledge in best practices and standards in EU and Asia Pacific regulatory requirements  Solid experience with CMC, clinical, and nonclinical development and regulatory submissions A commitment to excellence putting the science and the patients first Self-motivated, independent, influential leader who understands risk and risk management in a small company environment Possesses a cross-functional collaborative skill set and brings strong analytical thinking and strategic perspective Comfortable with owning and decision making within the scope of regulatory affairs and operations About OnKure:  We are a clinical-stage biopharmaceutical company focused on discovering and developing precision medicines that target biologically validated drivers of diseases underserved by available therapies. Using a structure- and computational chemistry-driven drug design platform, we are committed to improving clinical outcomes for patients by building a robust pipeline of small-molecule drugs designed to selectively target specific mutations thought to be key drivers of cancer and vascular anomalies. To attract the very best talent, OnKure offers a generous compensation and benefits package that includes competitive pay, performance-based bonus opportunities, stock options, insurance coverage (health, dental, life, and disability) for full-time employees, self-managed paid time off, and a 401(k) plan with company match. Candidates who live in or are willing to relocate to the Boulder, CO area are preferred. The annual compensation range for this role, based on experience, is $310,000-$350,000. OnKure is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, protected veteran status, disability, or any other protected factors.