Director, Regulatory

Benefits

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Application

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About this role

Director, Regulatory Greater Boston Area Position Summary The Director of Regulatory Affairs at MBX Biosciences will lead and execute global regulatory strategies that support the development and approval of MBX's clinical stage and early-stage programs. This high visibility role is responsible for developing and executing global regulatory strategies while leading the development and submission of critical regulatory filings-including INDs and CTAs-in alignment with evolving health authority expectations. In addition, this role will provide strategic regulatory leadership across MBX's early development portfolio, with a particular focus on obesity programs, ensuring proactive, scientifically grounded regulatory input from discovery through clinical advancement. Key Responsibilities - Provide regulatory leadership and strategic guidance across MBX's ‑early-stage development portfolio, ensuring regulatory considerations are integrated from discovery through ‑IND enabling activities. - Partner closely with R&D and Clinical teams to shape regulatory strategies for MBX's obesity portfolio, supporting efficient progression toward first‑in‑human studies and downstream clinical development. - Design and execute comprehensive global regulatory strategies and plans for assigned programs. - Develop and maintain proactive risk assessment and mitigation plans in collaboration with cross-functional teams and senior management. - Ensure timely and effective communication of regulatory developments to project teams, leadership, and key stakeholders, using sound judgment and professionalism. - Lead the regulatory sub-team and serve as the primary Regulatory Affairs representative on asset development teams. - Continuously expand therapeutic area knowledge to enhance strategic messaging and the quality of global regulatory submissions. - Act as a liaison with health authorities, including leading and managing FDA meetings.

Read the full description at mbxbio.com. FewerJobs shows a source-linked preview and links to the original posting.