Position SummaryThe 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.
- Drive continuous improvement by contributing to the evolution of regulatory processes and strategies, offering expert recommendations.
- Monitor and anticipate industry trends affecting regulatory and market access landscapes to inform and adapt product development and regulatory strategies.
- Other responsibilities as assigned.
Education & Qualifications - 10+ years of regulatory experience in life sciences or pharmaceuticals, particularly within early phase development (IND, CTA, innovative phase I and II trial design).
- Proven track record supporting clinical stage development; experience with Phase 1-3 programs is highly valuable.
- Experience leading IND/CTA submissions and interactions with FDA and EMA.
- Experience leading cross functional preparation for regulatory meetings.
- Demonstrate deep expertise in drug development and consistently exhibit leadership behaviors aligned with senior-level expectations.
- Exceptional organizational skills and attention to detail, with a demonstrated ability to manage multiple priorities efficiently.
- Possesses a deep understanding of FDA and EMA requirements
- Strong judgment and time management skills, with the ability to balance concurrent projects and make strategic decisions under pressure.
- Collaborative and adaptable work style, with excellent written and verbal communication skills and a pragmatic, solutions-oriented approach.
- Thrives in a fast-paced, evolving environment and enjoys working cross-functionally to drive innovation and business success.
Travel &Schedule:This role operates in a hybrid work model, with an expectation of an average of three on-site days per week at the Burlington site. The position also requires periodic travel aligned with business needs, including participation in Together Weeks (once a quarter) and functional or company meetings, as directed by the Company.
