Senior Regulatory Affairs Associate

Preparing regulatory agency submissions, the full-time Senior Regulatory Affairs Associate will manage the preparation, review, and submission of CTAs and INDs for various drug products while working remotely. Key responsibilities Prepare, review, and submit CTAs and INDs to regulatory agencies, including Health Canada and FDA Conduct gap analysis of regulatory documents and maintain regulatory submissions, including amendments and annual reports Communicate and consult with regulatory agencies to ensure compliance and address information requests Required qualifications Bachelor's degree in Life Sciences; Master's degree preferred Minimum of 2 years of experience in a regulatory field RACS certification is a strong benefit Thorough understanding of clinical research and drug development processes Fluency in English, with strong writing and communication skills