Global Regulatory Affairs Lead: Strategy & Submissions

Takeda; Cambridge (MA); Hybrid; USD 154,000 - 243,000; Full time

Job summary

Takeda in Cambridge, MA seeks an Associate Director to define and lead global regulatory strategies for complex programs, providing strategic and tactical guidance to cross-functional teams while ensuring compliance with FDA and global regulatory requirements.

The role oversees US FDA submissions, stakeholder communications, and staff mentorship in a hybrid work setting. A scientific advanced degree and 6+ years in pharma with regulatory experience are preferred.

Qualifications

• Advanced degree in scientific discipline (PharmD/PhD/MD) strongly preferred.
• 6+ years of pharmaceutical industry experience, including 4+ years in regulatory experience.
• Experience in reviewing, authoring, or managing regulatory submissions.

Responsibilities

• Define strategies and provide tactical guidance to teams to ensure global regulatory success.
• Ensure global regulatory strategies are implemented and maintained with changing regulatory needs.
• Lead FDA meetings and act as the primary contact with health authorities.

Skills

Leadership

Regulatory strategy

Cross-functional collaboration

Regulatory communication

Timeline management

Negotiation skills

Team mentorship

Education

Advanced degree in scientific discipline (PharmD/PhD/MD)

Job description

Takeda in Cambridge, MA seeks an Associate Director to define and lead global regulatory strategies for complex programs, providing strategic and tactical guidance to cross-functional teams while ensuring compliance with FDA and global regulatory requirements.

The role oversees US FDA submissions, stakeholder communications, and staff mentorship in a hybrid work setting. A scientific advanced degree and 6+ years in pharma with regulatory experience are preferred.