Job Description
Position Summary
We are seeking a Regulatory Strategist – CMC to support global regulatory strategy and execution across the product lifecycle. This 12‑month contract, renewable, is remote (Canada). The 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
- Develop and execute CMC regulatory strategies for new product development and product lifecycle management.
- Support regulatory strategy planning and act as a key contributor to dossier planning for global submissions.
- Provide regulatory input on CMC development activities, change management, and post‑approval strateg...