Senior Manager, GRA Marketed Products

Role: Senior Manager, GRA Marketed Products, leading global regulatory strategies for Takeda’s marketed pharmaceutical products. Responsibilities: oversee global regulatory team and sub-groups, define and execute regulatory strategies, manage US FDA submissions and approvals, serve as FDA contact, collaborate with regional and global teams, oversee vendor activities, and lead regulatory due diligence for licensing. Maintain compliance with US, EU, and Health Canada regulations, monitor regulatory trends, and partner with market access teams on value evidence. Requirements: Bachelor’s in Pharmacy or related field; 6+ years of healthcare regulatory experience applying FDA, EU, and Health Canada regulations; proven track record managing global regulatory submissions, leading agency negotiations, and maintaining product registration. High-Value: global pharmaceutical products, marketed stage, US/EU/Canada regulatory compliance, FDA interactions, vendor management, licensing due diligence, remote work up to 80%. Location: Cambridge, MA, with flexible remote work options.