Global Regulatory Affairs Senior Manager, Marketed Products

Regulatory Jobs; Boston (MA); Remote; USD 201,000 - 215,000; Full time

Job summary

Takeda Development Center Americas, Inc. is seeking a Senior Manager, Global Regulatory Affairs, Marketed Products to lead regulatory submissions and strategy across regions. This role requires coordinating with GRL and regional leads, and guiding cross-functional teams to ensure compliance with regulatory requirements.

The position supports up to 75% remote work with up to 30% domestic travel, and offers a compensation range aligned with market expectations for senior regulatory professionals.

Qualifications

• Bachelor's degree in Pharmacy, Pharmaceutical Science, Chemistry, Biology, or related field.
• 4+ years of related regulatory experience required.
• Experience with regulatory submissions to US FDA, EU, and other authorities.

Responsibilities

• Assist GRL and global regulatory leads to ensure timely submissions.
• Collaborate cross-functionally to update and execute global regulatory strategy.
• Review regulatory documents for clinical trials and submissions.
• Support Health Authority meetings and responses.

Skills

Regulatory submissions

Cross-functional collaboration

Regulatory strategy

Education

Bachelor's degree in Pharmacy, Pharmaceutical Science, Chemistry, Biology, or related field

Tools

Regulatory EDMS

Job description

Takeda Development Center Americas, Inc. is seeking a Senior Manager, Global Regulatory Affairs, Marketed Products to lead regulatory submissions and strategy across regions. This role requires coordinating with GRL and regional leads, and guiding cross-functional teams to ensure compliance with regulatory requirements.

The position supports up to 75% remote work with up to 30% domestic travel, and offers a compensation range aligned with market expectations for senior regulatory professionals.