Director, Regulatory
MBX Biosciences, Inc.
June 29, 2026
Remote friendly (Greater Boston)
United States
Corporate Functions
Position Summary
The Director of Regulatory Affairs will lead and execute global regulatory strategies supporting the development and approval of MBX’s clinical stage and early-stage programs, including regulatory filings (INDs and CTAs) in alignment with health authority expectations. Provide strategic regulatory leadership across the early development portfolio with a focus on obesity programs, ensuring proactive, scientifically grounded regulatory input from discovery through clinical advancement.
Key Responsibilities
- Provide regulatory leadership and integrate regulatory considerations from discovery through IND-enabling activities.
- Partner with R&D and Clinical teams to shape regulatory strategies for the obesity portfolio.
- Design and execute comprehensive global regulatory strategies and plans.
- Develop and maintain proactive risk assessment and mitigation plans with cross-functional teams.
- Communicate regulatory developments to project teams, leadership, and stakeholders.
- Lead the regulatory sub-team and serve as primary Regulatory Affairs representative on asset development teams.
- Expand therapeutic area knowledge to improve regulatory submission quality and messaging.
- Liaise with health authorities, including leading and managing FDA meetings.
- Contribute to continuous improvement of regulatory processes and strategies.
- Monitor and anticipate industry trends impacting regulatory and market access.
Qualifications
- 10+ years regulatory experience in life sciences/pharmaceuticals, especially early phase development (IND/CTA, Phase I–II design).
- Experience supporting clinical stage development (Phase 1–3 highly valuable).
- Experience leading IND/CTA submissions and FDA/EMA interactions.
- Experience leading cross-functional preparation for regulatory meetings.
- Deep expertise in drug development and senior-level leadership behaviors.
- Strong organization, attention to detail, judgment, and time management.
- Understanding of FDA and EMA requirements.
- Excellent written/verbal communication; collaborative and solutions-oriented.
Travel & Schedule
- Hybrid work; average of three on-site days/week in Burlington.
- Periodic travel for business needs and meetings (including Together Weeks quarterly).
The Director of Regulatory Affairs will lead and execute global regulatory strategies supporting the development and approval of MBX’s clinical stage and early-stage programs, including regulatory filings (INDs and CTAs) in alignment with health authority expectations. Provide strategic regulatory leadership across the early development portfolio with a focus on obesity programs, ensuring proactive, scientifically grounded regulatory input from discovery through clinical advancement.
Key Responsibilities
- Provide regulatory leadership and integrate regulatory considerations from discovery through IND-enabling activities.
- Partner with R&D and Clinical teams to shape regulatory strategies for the obesity portfolio.
- Design and execute comprehensive global regulatory strategies and plans.
- Develop and maintain proactive risk assessment and mitigation plans with cross-functional teams.
- Communicate regulatory developments to project teams, leadership, and stakeholders.
- Lead the regulatory sub-team and serve as primary Regulatory Affairs representative on asset development teams.
- Expand therapeutic area knowledge to improve regulatory submission quality and messaging.
- Liaise with health authorities, including leading and managing FDA meetings.
- Contribute to continuous improvement of regulatory processes and strategies.
- Monitor and anticipate industry trends impacting regulatory and market access.
Qualifications
- 10+ years regulatory experience in life sciences/pharmaceuticals, especially early phase development (IND/CTA, Phase I–II design).
- Experience supporting clinical stage development (Phase 1–3 highly valuable).
- Experience leading IND/CTA submissions and FDA/EMA interactions.
- Experience leading cross-functional preparation for regulatory meetings.
- Deep expertise in drug development and senior-level leadership behaviors.
- Strong organization, attention to detail, judgment, and time management.
- Understanding of FDA and EMA requirements.
- Excellent written/verbal communication; collaborative and solutions-oriented.
Travel & Schedule
- Hybrid work; average of three on-site days/week in Burlington.
- Periodic travel for business needs and meetings (including Together Weeks quarterly).