Join ClinChoice Canada Inc. as a Regulatory Strategist CMC, focusing on global regulatory strategies and high-quality submissions for product lifecycles. This role emphasizes collaboration with CMC, Quality, and Manufacturing teams.
In this position, you will create and implement CMC regulatory strategies, streamline regulatory submissions to U.S. FDA and Health Canada, and participate in post-approval activities. Ideal candidates should possess strong technical CMC knowledge and hands-on submission experience.
Key Responsibilities:
• Develop CMC regulatory strategies for product lifecycle management
• Prepare submissions for U.S. FDA and Health Canada
• Review CMC documentation and perform DMF assessments
• Manage post-approval submissions for regulatory compliance
• Coordinate timely responses to FDA Information Requests
Requirements:
• Bachelor’s degree in relevant field; advanced degree preferred
• 3+ years in CMC regulatory affairs expertise
• Expe...