Join Syneos Health as a remote CMC Regulatory Consultant, specializing in biologics for the Canadian market. Contribute your regulatory expertise to support client submissions and life cycle management. As a CMC Regulatory Consultant at Syneos Health, you will play a critical role in facilitating submissions to Health Canada for a biologic and small molecule product portfolio.

Your experience is crucial for Level III submissions, sNDS submissions, periodic quality reviews, and coordinating Clarifax responses with Health Canada. Work independently to provide regulatory intelligence and guidance, utilizing your knowledge of CMC authoring processes. Key Responsibilities:

- Manage client submissions to Health Canada effectively




- Handle Level III and sNDS submissions accurately
- Conduct annual drug notifications and PQRs
- Coordinate responses to Clarifax inquiries
- Provide local regulatory intelligence in Canada Requirements:
- Significant experience with CMC authoring
- Proven interaction history with Health Canada
- Ability to work independently on submissions
- Familiarity with biologic products and regulations
- Expertise in life cycle management submissions Leverage your regulatory knowledge to enhance the success of biologics and small molecules in Canada.

📌 Remote CMC Regulatory Consultant at Syneos Health (Canada)
🏢 Syneos Health
📍 Canada