Director, Regulatory Site CMC

The Director, Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level. This role leverages ICH Q12 principles to streamline post-approval change management and explores automation to enhance predictability and repeatability in regulatory processes.

Requirements

• BS/BA Degree in a Scientific Discipline
• 10+ years of overall biopharmaceutical/device industry experience
• 8+ years of direct Regulatory CMC or Regulatory Device experience
• Strong practical experience with global HA requirements, beyond EU/US
• Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support
• Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams

Benefits

• Medical, dental, vision insurance
• 401(k) plan and company match
• Short-term and long-term disability coverage
• Basic life insurance
• Tuition reimbursement program
• Paid volunteer time off
• Company holidays
• Well-being benefits