Global Regulatory CMC Lead (Franchise)

Takeda; Boston (MA); On-site; USD 177,000 - 278,000; Full time

Job summary

Takeda seeks an accomplished GRA CMC Franchise Lead in Boston to independently develop and execute regulatory CMC strategies for TAK-079 across clinical development and lifecycle management. You will partner with Regulatory, Development and Commercial teams to drive major global submissions and ensure regulatory compliance.

The role requires a proven track record in global CMC submissions, strong leadership, and the ability to communicate complex regulatory strategies to cross‑functional

Qualifications

• BS/BA in a scientific discipline; an advanced degree is preferred.
• 10+ years in biopharma with 8+ years Regulatory CMC; experience leading major submissions.
• Experience communicating regulatory strategy to development, registration and post‑market teams.
• Ability to lead or contribute to global regulatory CMC submissions and lifecycle activities.

Responsibilities

• Be the GRA CMC Franchise Lead for TAK-079 and lead regulatory CMC strategy.
• Lead execution of regulatory CMC investigational, registration and post‑approval strategies.
• Represent Regulatory, Pharmaceutical Development and Commercial teams in project discussions.
• Demonstrate leadership and deep knowledge of GRA CMC regulations to improve submission success.
• Coach and develop team members and foster high‑performance culture.
• Communicate issues and regulatory risks to leadership in a timely manner.

Skills

Regulatory strategy

Leadership

Global submissions

Regulatory CMC

Regulatory communication

Education

BS/BA Degree in a Scientific Discipline

Advanced Degree (M.S., Ph.D.)

Job description

Takeda seeks an accomplished GRA CMC Franchise Lead in Boston to independently develop and execute regulatory CMC strategies for TAK-079 across clinical development and lifecycle management. You will partner with Regulatory, Development and Commercial teams to drive major global submissions and ensure regulatory compliance.

The role requires a proven track record in global CMC submissions, strong leadership, and the ability to communicate complex regulatory strategies to cross‑functional