Associate Director, Global Regulatory Science, CMC

As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.

Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide.

In Laval, Moderna's long-term strategic partnership with the Canadian Government is revolutionizing the nation's pandemic preparedness and response capabilities. Our upcoming state-of-the-art mRNA vaccine manufacturing facility will play a pivotal role in ensuring rapid access to vaccines for respiratory viruses, contingent on Health Canada's approval. By investing in local talent development and fostering research and development collaborations, we're cementing Canada's position as a global center of mRNA excellence.

Join us as we build a resilient future in biotechnology and healthcare innovation.

You will be responsible for leading the regulatory CMC strategy and execution for one or more programs, with a strong emphasis on Canadian regulatory requirements. You will design and implement Canada-specific strategies for CMC regulatory submissions and provide expert guidance to CMC teams and internal partners. As a key liaison with Health Canada, you will ensure timely and compliant submissions and help shape Moderna’s presence in Canada’s regulatory landscape.

This is a pivotal opportunity to support the lifecycle of transformative mRNA medicines while operating in a fast-paced, high-impact environment.

Here’s

What You’ll Do:

Your key responsibilities will be:

• Develop and implement regulatory CMC strategies for Canadian submissions (e.g., CTA, NDS, SNDS, NC).

• Author, review, and oversee the preparation of CMC and Quality-related documentation for Health Canada.

• Lead regulatory CMC discussions and interactions with Health Authorities to facilitate timely approvals.

• Act as the local submission lead for all CMC aspects of the regulatory dossier.

• Provide expert CMC regulatory advice to Manufacturing, Quality, and Process/Analytical Development teams.

• Ensure all CMC submissions meet Health Canada guidelines and are submission-ready.

• Identify and manage regulatory risks, proposing mitigation strategies as needed.

• Follow all relevant GxP regulations and internal procedures to maintain compliance.

Your responsibilities will also include:

• Assess and provide guidance on quality/manufacturing change controls.

• Develop and maintain CMC submission tools, templates, and regulatory processes.

• Interpret Health Canada guidance documents, regulations, and directives and advise internal stakeholders accordingly.

• Collaborate closely with the Canadian Quality Assurance lead to support submissions, including Drug Establishment License (DEL) applications.

• Contribute to post-Notice of Compliance (NoC) activities, such as quality changes and the Yearly Biologic Product Report (YBPR).

• Ensure strategic alignment of regulatory initiatives with business priorities while adapting in a dynamic environment.

The key Moderna Mindsets you’ll need to succeed in the role:

• We behave like owners. The solutions we’re building go beyond any job description.
  In this role, you will operate independently and take full ownership of Canada-specific CMC submissions, serving as the key regulatory point of contact. Your proactive mindset will ensure both regulatory excellence and alignment with broader business goals.

• We digitize everywhere possible using the power of code to maximize our impact on patients.
  You’ll leverage Moderna’s digital-first tools and CMC submission templates to enhance quality, consistency, and efficiency. Your ability to optimize regulatory workflows through innovation will have a direct impact on accelerating access to medicine in Canada.

Here’s What You’ll Bring to the Table:

• BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry,…