Description:

The Associate Director, Global Regulatory Science, CMC is responsible for leading the end-to-end regulatory CMC strategy for Moderna’s Canadian submissions across one or more mRNA programs. This includes developing submission strategies, preparing CMC documentation, and serving as Moderna’s primary liaison with Health Canada for all CMC-related matters. The role is highly strategic and influential, supporting lifecycle management and accelerating access to mRNA medicines in Canada. The position is based in Laval as part of Moderna’s new Canadian mRNA vaccine manufacturing initiative.

Key Responsibilities:

• Lead CMC regulatory strategy for Canadian submissions (CTA, NDS, SNDS, NC)

• Author, review, and manage CMC and Quality documentation for Health Canada

• Serve as primary Health Canada liaison for regulatory CMC discussions

• Act as local CMC submission lead for all regulatory dossiers

• Provide expert regulatory guidance to Manufacturing, Quality, and Process/Analytical Development teams

• Ensure all submissions comply with Health Canada regulations and internal GxP requirements

• Identify regulatory risks and implement mitigation strategies

• Support post-Notice of Compliance activities (quality changes, YBPR)

• Manage change controls and provide regulatory recommendations

• Maintain tools, templates, and regulatory processes for CMC

• Collaborate with Canadian QA lead on DEL (Drug Establishment License) and other submissions

• Ensure alignment with Moderna’s global business priorities in a fast-paced environment

Qualifications:

• BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or related field

• 8+ years pharma/biotech experience (manufacturing, analytic, or both)

• 5+ years in Regulatory CMC for biologics

• Strong expertise in Health Canada regulations, CTD format, and CMC lifecycle management

• Experience with Health Canada regulatory procedures for drug development and registration

• Ability to work independently and effectively in a matrixed, cross-functional environment

• Exceptional written and verbal communication

• Must have at least 2 years of work authorization for Canada

Desired Characteristics:

• Ownership mindset; ability to operate autonomously

• Strategic thinker with strong problem-solving and risk-assessment skills

• Digitally fluent and comfortable using regulatory workflow tools

• Collaborative, proactive, and adaptable

• High attention to detail with strong organizational skills

• Strong interpersonal and leadership qualities

• Ability to navigate fast-moving, high-impact biotech environments

Additional Requirements & Notes:

• Moderna follows a 70% in-office, 30% remote work model

• Smoke-free, drug-free, alcohol-free workplace

• Strong commitment to DEI and equal opportunity employment

• Reasonable accommodations available upon request

• Comprehensive global benefits: insurance, wellness accounts, paid time off, recharge days, adoption & family planning benefits, and more