Director of Regulatory Affairs

Job Summary

To support a growing team in CMC Regulatory Affairs, the full-time Director of Regulatory Affairs will provide expert knowledge on small and large molecules, manage regulatory CMC submission documents, and facilitate communication with clients and government agencies, with the flexibility to work remotely or onsite.

Key responsibilities

• Serve as a technical expert in the development, testing, and manufacturing of Biologics while advising ICON colleagues and clients
• Manage the preparation of regulatory CMC submission documents for various applications and oversee submission approvals
• Develop regulatory strategies and provide strategic advice to clients based on regulatory experience

Required qualifications

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