Director of Regulatory Affairs

Job Summary

A company is looking for a Director, Regulatory Affairs - CMC.

Key Responsibilities

• Serve as a technical expert in development, testing, and manufacturing of Biologics and provide advice to colleagues and clients
• Manage the preparation of regulatory CMC submission documents and facilitate submission approvals through effective communication
• Monitor new regulatory requirements and provide strategic advice to clients based on regulatory experience

Required Qualifications and Education

• Bachelor's degree in a relevant discipline, preferably in life sciences or healthcare
• Advanced degree (MSc., PhD., M.D., Pharm.D., MBA) in a related field is beneficial
• Relevant experience in pharmaceutical or biologics regulatory environments (e.g., US, EU, Canada)
• Demonstrable experience in a regulatory CMC role during drug development and product maintenance
• Certification in regulatory affairs (RAC) or relevant post-secondary education is beneficial