Global GRA CMC Franchise Lead

Orangetheory - Franchise #0137; Boston (MA); Hybrid; USD 177,000 - 278,000; Full time

Job summary

Takeda seeks an experienced GRA CMC leader to drive regulatory strategies and submissions across global programs. You will lead CMC aspects of registrational submissions, coordinate with development teams, and ensure regulatory compliance throughout product lifecycles.

The role requires strong leadership, excellent communication, and a track record of successful interactions with health authorities in complex regulatory contexts. Hybrid work and a Boston, MA location are supported.

Qualifications

• 10+ years in biopharmaceutical/regulatory CMC and/or devices, with major submissions experience.
• Strong understanding of regulatory CMC requirements for global development and post‑market support.
• Excellent written and oral communication skills and leadership capability.
• Ability to lead regulatory strategy discussions with drug development and commercial teams.
• Experience coordinating with health authorities and cross‑functional partners.

Responsibilities

• Lead major global registrational submissions and CMC strategies.
• Guide teams on dossier content and regulatory reviews for conformance with requirements.
• Represent GRA CMC in health authority meetings and prepare for regulatory discussions.
• Provide regulatory guidance on administrative topics with international authorities as needed.
• Coach teams and ensure regulatory compliance across programs.

Skills

Regulatory Leadership

CMC Regulatory

Regulatory Strategy

Cross-Functional Teams

Education

BS/BA in Science

MS/PhD preferred

Job description

Takeda seeks an experienced GRA CMC leader to drive regulatory strategies and submissions across global programs. You will lead CMC aspects of registrational submissions, coordinate with development teams, and ensure regulatory compliance throughout product lifecycles.

The role requires strong leadership, excellent communication, and a track record of successful interactions with health authorities in complex regulatory contexts. Hybrid work and a Boston, MA location are supported.