The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level, supporting diverse modalities and leveraging an agile approach
Job Summary
The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level, supporting diverse modalities and leveraging an agile approach.
This position drives standardization, scalability, and sustainability in regulatory processes, exploring automation to enhance predictability and repeatability.
Takeda offers stimulating careers, encourages innovation, and strives for excellence in a collaborative workplace, fostering an inclusive culture.
Matching Summary
The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level, supporting diverse modalities and leveraging an agile approach.
Salary
Base: $177,000.00 - $278,080.00; Bonus/Equity: Not specified; Benefits: Medical, dental, vision, 401(k), disability, life insurance, tuition reimbursement, PTO
Skills & Requirements
Must-have
Global HA requirements beyond EU/US
ICH Q12 principles
Regulatory CMC requirements
Small molecules and biologics
External manufacturing sites
Nice-to-have
Agile approach
Automation technologies
Inclusive culture
Teamwork and collaboration
Key Requirements
BS/BA Degree in a Scientific Discipline
10+ years biopharmaceutical/device industry experience
8+ years Regulatory CMC or Regulatory Device experience
Strong practical experience with global HA requirements
Proven ability to understand and communicate regulatory strategy