Site CMC Regulatory Director: Global Change & Submissions

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

Benefits offered by this job

Perks are not listed in the ad

Job summary

Takeda in Boston, MA is seeking a Director Regulatory Site CMC to lead site-specific post-approval change management and regulatory submissions across small molecule and biologics. This role requires 10+ years in biopharma with deep global HA regulatory experience, an advanced scientific degree, and proven ability to communicate regulatory strategy to cross-functional teams.

The position offers a hybrid work arrangement, competitive compensation, and opportunities to drive standardization and

Qualifications

• BS/BA degree in a scientific discipline; advanced degree preferred.
• 10+ years in biopharma with 8+ years regulatory CMC or regulatory device experience.
• Strong global HA regulatory experience beyond EU/US.
• Ability to communicate regulatory strategy to cross-functional teams.
• Excellent written and oral communication; leadership and teamwork.

Responsibilities

• Lead site-specific post-approval change management activities and regulatory submissions.
• Apply ICH Q12-based, risk-based approaches to post-approval changes.
• Promote standardized processes and tools for scalable site-based regulatory work.
• Explore automation to improve efficiency and repeatability in change control.
• Provide centralized regulatory support for multiple sites and external partners.
• Collaborate with external sites to align change control with global expectations.
• Ensure site compliance by risk-based evaluation of changes.
• Coordinate with global Regulatory CMC in cross-functional Change Review meetings.
• Implement streamlined workflows leveraging digital tools.
• Promote sustainable, scalable site-level regulatory operations.

Skills

Regulatory CMC

Global HA requirements

Leadership

Regulatory strategy

Communication

Education

BS/BA in a Scientific Discipline

MS/PhD preferred

Job description

Takeda in Boston, MA is seeking a Director Regulatory Site CMC to lead site-specific post-approval change management and regulatory submissions across small molecule and biologics. This role requires 10+ years in biopharma with deep global HA regulatory experience, an advanced scientific degree, and proven ability to communicate regulatory strategy to cross-functional teams.

The position offers a hybrid work arrangement, competitive compensation, and opportunities to drive standardization and