Global Regulatory CMC Director - Submissions Lead (Hybrid)

USA - 3316 Takeda Development Center Americas, Inc.; Cambridge (MA); Hybrid; USD 177,000 - 278,000; Full time

Job summary

Takeda in Boston, MA is seeking an experienced GRA CMC Product Lead to develop and oversee regulatory CMC strategies for assigned products, guiding submissions from development through lifecycle.

You will represent Regulatory, Pharmaceutical Development, and Commercial teams in Health Authority meetings, mentor GRA CMC members, and drive regulatory compliance across global programs in a hybrid work model.

Qualifications

• BS/BA degree in a scientific discipline; MS/PhD preferred.
• 10+ years in biopharma/devices with 8+ years regulatory CMC experience.
• Experience leading major NDA/NDA-like submissions.
• Ability to communicate regulatory strategy to cross-functional teams.
• Strong judgment and regulatory intelligence usage.

Responsibilities

• Develops and oversees regulatory CMC submissions per strategy.
• Guide content and conformance for dossier reviews.
• Represent GRA CMC in Health Authority meetings.
• Mentor GRA CMC team members and stakeholders.
• Ensure regulatory compliance across product lifecycle.

Skills

Regulatory CMC

GRA CMC

Regulatory Submissions

Cross-functional leadership

Mentoring

Education

BS/BA in Scientific Discipline

Advanced degree (MS/PhD)

Job description

Takeda in Boston, MA is seeking an experienced GRA CMC Product Lead to develop and oversee regulatory CMC strategies for assigned products, guiding submissions from development through lifecycle.

You will represent Regulatory, Pharmaceutical Development, and Commercial teams in Health Authority meetings, mentor GRA CMC members, and drive regulatory compliance across global programs in a hybrid work model.