Director, Regulatory Site CMC

Company Name: Takeda

Job Description

The Director, Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level. This role supports diverse modalities, driving standardization, scalability, and sustainability through agile approaches and automation.

Key Responsibilities

• Leverage ICH Q12 principles for change management
• Collaborate with external manufacturing sites

Requirements

• BS/BA in a scientific discipline
• 10+ years of biopharmaceutical/device industry experience
• At least 8 years in Regulatory CMC or Regulatory Device experience
• Strong practical experience with global Health Authority requirements beyond EU/US