Senior Global Regulatory Affairs Manager, Marketed Products

Takeda Pharmaceutical Company Limited; Boston (MA); Hybrid; 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 for global products.

You will work with GRL and regional leads to ensure compliance and timely filings, with substantial collaboration across Clinical Science, Safety, and Regulatory Operations. Position offers up to 75% remote work and up to 30% travel.

Qualifications

• Bachelor's degree in Pharmacy, Pharmaceutical Science, Chemistry, Biology, or related field, plus 4 years of related experience.
• Experience with Regulatory submissions to US FDA, EU, and other health authorities.
• Ability to manage regulatory submissions timing and cross-functional reviews.

Responsibilities

• Assist the Global Regulatory Lead and collaborate with regional leads to ensure timely submissions.
• Lead and coordinate regulatory activities for ongoing clinical trials and submissions.
• Provide strategic guidance on regulatory interactions and health authority meetings.

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 for global products.

You will work with GRL and regional leads to ensure compliance and timely filings, with substantial collaboration across Clinical Science, Safety, and Regulatory Operations. Position offers up to 75% remote work and up to 30% travel.