Regulatory Strategist Consultant - CMC

Job description

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a CMC Strategist Consultant with HYBRID option in CANADA for 12 months CONTRACT and renewable , to join one of our major consumer products clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. Position Summary: We are seeking a Regulatory Strategist – CMC to support global regulatory strategy and execution across the product lifecycle. This role will be responsible for developing and implementing CMC regulatory strategies, preparing and reviewing high-quality regulatory submissions, and supporting post-approval activities for U.S. FDA and Health Canada. The ideal candidate brings strong technical CMC knowledge, hands-on submission experience, and the ability to partner cross-functionally with CMC, Quality, and Manufacturing teams. Key Responsibilities: Regulatory Strategy & Planning: Regulatory Submissions (U.S. FDA & Health Canada) - Develop and execute CMC regulatory strat...