CMC Regulatory Consultant

CMC Regulatory Consultant (6-month contract, 10 hours per week)

Hamilton, ON

Introduction

We are hiring a CMC Regulatory Consultant for one of our radiopharmaceutical clients based in Hamilton, Ontario. The CMC Regulatory Consultant reporting into the Director, Technical Operations, will support global regulatory interactions by leading the coordination, review and regulatory alignment of Health Authority Questions (HAQs) related to CMC. This role serves as the primary liaison between internal cross-functional technical SMEs and Regulatory Affairs, ensuring that SME-authored responses are aligned with regional regulatory expectations. The company has recently opened a state-of-the-art radiopharmaceutical manufacturing facility. The good manufacturing practice (GMP) compliant facility is now operational supplying patients for clinical trials. As part of the company’s radiopharmaceutical manufacturing department, the CMC Regulato...