Director, Regulatory
MBX Biosciences, Inc., Boston, MA, United States
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.
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.
EEO Statement MBX Biosciences is an Equal Opportunity Employer and is committed to treating all applicants fairly without discrimination. We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.
#J-18808-Ljbffr
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.
EEO Statement MBX Biosciences is an Equal Opportunity Employer and is committed to treating all applicants fairly without discrimination. We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.
#J-18808-Ljbffr