MBX Biosciences

Director, Regulatory

Greater Boston Area · Director

Sponsorship not specifiedDetected 29 days ago

FDA RegulatoryAnimal StudiesLeadershipCommunicationCollaborationTime ManagementAdaptabilityOrganizational SkillsRegulatory Affairs

About the role

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 is based in Carmel, Indiana and Burlington, Massachusetts.

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.
Lead the regulatory sub-team and serve as the primary Regulatory Affairs representative on asset development teams.
Drive continuous improvement by contributing to the evolution of regulatory processes and strategies, offering expert recommendations.
10+ years of regulatory experience in life sciences or pharmaceuticals, particularly within early phase development (IND, CTA, innovative phase I and II trial design).
Exceptional organizational skills and attention to detail, with a demonstrated ability to manage multiple priorities efficiently.

Proven track record supporting clinical stage development
experience with Phase 1-3 programs is highly valuable.
Proven track record supporting clinical stage development; experience with Phase 1-3 programs is highly valuable.

Act as a liaison with health authorities, including leading and managing FDA meetings.

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.
To learn more, please visit the Company website at www.mbxbio.com and follow it on LinkedIn.

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.

This listing is sourced directly from MBX Biosciences's careers page and normalized into a canonical job model.