Associate Director, Global Regulatory Affairs CMC Lead

USA - 3316 Takeda Development Center Americas, Inc.; Cambridge (MA); On-site; USD 140,000 - 210,000; Full time

Job summary

Takeda's Global Regulatory Affairs - CMC team in Cambridge, MA is seeking a Regulatory CMC professional to lead regulatory submissions for investigational, registration and post-approval programs across global markets.

With minimal supervision, you will define CMC content, develop regulatory strategies, collaborate with cross-functional teams and Health Authorities, and ensure regulatory compliance with Takeda procedures and global requirements.

Qualifications

• Regulatory CMC knowledge
• Experience with regulatory submissions
• Strong communication and collaboration skills

Responsibilities

• Lead regulatory CMC submissions for investigational, registration and post-approval programs
• Serve as RA CMC member on Global Regulatory CMC team
• Interact with Health Authorities and internal/external partners
• Define CMC content requirements for regulatory submissions
• Ensure conformance with Takeda procedures and global regulatory standards

Job description

Takeda's Global Regulatory Affairs - CMC team in Cambridge, MA is seeking a Regulatory CMC professional to lead regulatory submissions for investigational, registration and post-approval programs across global markets.

With minimal supervision, you will define CMC content, develop regulatory strategies, collaborate with cross-functional teams and Health Authorities, and ensure regulatory compliance with Takeda procedures and global requirements.