Description
Altasciences is hiring a Senior Regulatory Affairs Associate to prepare, review, and submit regulatory agency filings for small molecules, biologics, natural health products, and combination drug-medical devices. The role manages CTAs, INDs, consultation meetings, regulatory responses, amendments, annual reports, controlled-substance exemption applications, regulatory databases, document gap analyses, and regulatory intelligence while liaising with Health Canada and the FDA. It requires a bachelor's degree in Life Sciences, at least two years of related regulatory experience, strong knowledge of clinical research, drug development, and applicable guidance, excellent communication and critical-thinking skills, and English fluency.
