Director, Regulatory

MBX Biosciences, Inc.; Boston (MA); Hybrid; USD 180,000 - 240,000; Full time

Job summary

MBX Biosciences is seeking a Director of Regulatory Affairs to lead global regulatory strategies for its clinical stage programs, including INDs and CTAs, in alignment with health authority expectations. The role provides strategic regulatory leadership across early development, with a focus on obesity programs, guiding discovery through clinical advancement.

The successful candidate will partner with R&D and Clinical teams, manage FDA/EMA interactions, and oversee regulatory submissions and

Qualifications

• 10+ years of regulatory experience in life sciences or pharma, especially early development (IND/CTA, Phase I/II).
• Proven track record with clinical stage development; Phase 1–3 experience valuable.
• Experience leading IND/CTA submissions and FDA/EMA interactions.
• Leadership across cross-functional teams with strategic regulatory vision.

Responsibilities

• Provide regulatory leadership and strategic guidance across MBX’s early-stage portfolio.
• Shape regulatory strategies for obesity portfolio to enable first-in-human studies.
• Design and execute global regulatory plans for assigned programs.
• Lead regulatory meetings with health authorities (FDA/EMA) and communicate updates to teams.
• Drive process improvements and risk mitigation with cross-functional partners.

Skills

Regulatory leadership

Cross-functional collaboration

Regulatory strategy

FDA/EMA liaison

Project management

Job description

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.

Company Overview

MBX Biosciences is a biopharmaceutical company focused on the discovery, development and commercialization of novel precision peptide therapies based on its proprietary PEP™ platform, for the treatment of endocrine and metabolic disorders. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs and large potential market opportunities. The Company’s pipeline includes canvuparatide (MBX 2109) for the treatment of chronic hypoparathyroidism preparing for Phase 3 development; and an obesity portfolio that includes MBX 4291 in Phase 1 development and MBX 5765 in preclinical development, as well as additional discovery candidates. The Company is based in Carmel, Indiana and Burlington, Massachusetts. To learn more, please visit the Company website at www.mbxbio.com and follow it on LinkedIn.

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.