Associate Director

Description

Develop and implement effective CMC regulatory strategies for Canadian submissions (CTA, NDS, SNDS, NC).
Write, review, and oversee the preparation of CMC and Quality documentation for Health Canada submissions.
Lead CMC regulatory discussions with health authorities to facilitate approvals.
Act as the local lead for submissions regarding all CMC aspects of the regulatory dossier.
Provide CMC regulatory guidance to the Manufacturing, Quality, and Process Development/Analytical teams.
Ensure all submissions comply with Health Canada guidelines.
Identify regulatory risks and propose mitigation strategies.
Adhere to all GxP regulatory requirements and internal procedures.

Qualifications

Bachelor's/Master's/PhD degree in molecular biology, pharmaceuticals, chemistry, chemical engineering, or a related field required.
Over 8 years of experience in the pharmaceutical/biotechnology industry, with a focus on manufacturing and/or analytics.
Over 5 years of experience in CMC regulations focused on biologics.
Direct experience and a strong understanding of current Health Canada CMC regulations, including the CTD format and the content of CMC regulatory submissions, particularly post-approval lifecycle management (PLM).
Knowledge of and extensive experience with Health Canada regulatory procedures related to the CMC aspects of drug development, product registration, and PLM.
Ability to collaborate effectively in a dynamic, cross-functional, matrix environment to achieve critical regulatory milestones.
Ability to work independently.
Excellent written and oral communication skills. As part of Moderna’s commitment to building a sustainable workforce, a minimum of 2 years of work authorization is required for this position.