Global Regulatory Affairs Sr Manager, Marketed Products

USA - 3316 Takeda Development Center Americas, Inc.; Cambridge (MA); À distance; USD 201 000 - 215 000; Plein temps

Résumé du poste

Takeda is seeking a Senior Manager, Global Regulatory Affairs, Marketed Products in Cambridge, MA to oversee regulation submissions and strategic regulatory activities for global marketed products. You will collaborate with GRL and regional leads to align with local requirements while driving efficient submissions.

Responsibilities include leading cross-functional teams, guiding health authority interactions, and shaping the global regulatory strategy with a focus on market access and

Qualifications

• Bachelor’s degree in Pharmacy, Pharmaceutical Science, Chemistry, Biology, or related field, plus 4 years of related experience.
• Experience with US FDA, EU and other health authorities regulatory submissions.
• Experience managing regulatory activities for ongoing clinical trials.
• Ability to author and manage review cycles for regulatory content.
• Experience planning and managing regulatory submissions.
• Regulatory intelligence and PRS analysis.
• Proficiency with Regulatory EDMS.

Responsabilités

• Assist the Global Regulatory Lead (GRL) and coordinate with regulatory regional leads to ensure global regulatory submissions are provided to local affiliates in compliance with regulations.
• In collaboration with GRL lead less complex multi-function submissions or support GRLs for more complex submissions.
• Provide strategic and tactical guidance to teams, including regulatory review of clinical trial documents and collaborate cross-functionally to ensure the global regulatory strategy is updated and executed.
• Assist the Global Regulatory Lead with Health Authority meetings and responses.
• Partner with functions responsible for market access and regional GRA leads to understand market access topics and strategize.
• Opportunities to strengthen product development plans and build into global integrated regulatory strategy.

Connaissances

Regulatory submissions

Strategic guidance

Cross-functional leadership

Regulatory intelligence

Formation

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

Outils

Regulatory EDMS

FDA/EMA knowledge

Description du poste

Takeda is seeking a Senior Manager, Global Regulatory Affairs, Marketed Products in Cambridge, MA to oversee regulation submissions and strategic regulatory activities for global marketed products. You will collaborate with GRL and regional leads to align with local requirements while driving efficient submissions.

Responsibilities include leading cross-functional teams, guiding health authority interactions, and shaping the global regulatory strategy with a focus on market access and