Associate Director, Regulatory Affairs

The Role

Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.

Moderna is strengthening its presence in Toronto, a leading biotech hub in Canada. Our team drives commercial operations to bring our mRNA medicines to patients nationwide. We welcome global talent ready to help transform medicine and improve lives.

This is an opportunity for an experienced regulatory leader to help shape the future of mRNA therapeutics in Canada. As part of a rapidly evolving environment, you will define regulatory strategy, lead critical submissions, and build strong partnerships across global and local teams to accelerate innovative medicines to patients. You'll also have the opportunity to work alongside cross-functional teams embracing digital innovation and emerging Generative AI tools to enhance regulatory excellence and decision‑making.

• Contribute to the success of the Canadian Regulatory Affairs team by fostering collaboration, alignment, accountability, and high-quality execution across multiple priorities and projects.
• Develop and influence Canadian regulatory strategy in close partnership with Global Regulatory Science and cross-functional stakeholders, ensuring Canadian regulatory requirements and business objectives are embedded within global development and commercialization plans.
• Lead the planning, preparation, review, and execution of Health Canada regulatory submissions, including Clinical Trial Applications (CTAs), New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), Health Canada meeting requests, post-Notice of Compliance (NOC) submissions, amendments, and supplements.
• Maintain accountability for successful regulatory outcomes by providing strategic oversight throughout the submission lifecycle.
• Deliver expert regulatory guidance across assigned development programs, proactively identifying potential regulatory risks, anticipating challenges, and driving effective solutions.
• Serve as the primary regulatory liaison with Health Canada for assigned programs, partnering with senior leadership to navigate complex regulatory discussions and support productive agency interactions.
• Contribute to the development and execution of clinical and pre‑clinical regulatory strategies across all phases of product development, from CTA through commercialization.
• Lead Canadian labelling activities, including Product Monographs and packaging, ensuring alignment with global positioning while maintaining compliance with Canadian regulatory requirements.
• Build and develop regulatory capability by mentoring junior Regulatory Affairs professionals, promoting continuous learning, knowledge sharing, and professional development.
• Lead proactive regulatory intelligence activities, monitoring evolving regulatory expectations and competitive landscapes to strengthen strategic planning and future decision‑making.
• Partner across functions to anticipate regulatory opportunities and risks, ensuring Canadian regulatory strategies support both immediate business priorities and long‑term organizational objectives.
• Champion strategic thinking, innovation, and continuous improvement within Regulatory Affairs, helping Moderna successfully navigate the evolving regulatory landscape for messenger RNA therapeutics.

• We obsess over learning. We don’t have to be the smartest we have to learn the fastest.
• We act with dynamic range, driving strategy and execution at the same time at every step.

• BA/BS degree in a scientific/engineering/healthcare discipline required, Master’s, PharmD or PhD preferred.
• 8+ years of progressively responsible experience in Regulatory Affairs or related field with significant experience leading Canadian regulatory strategy and submissions.
• Demonstrated leadership capabilities with the ability to influence and guide cross‑functional teams, and to represent Regulatory Affairs in senior‑level discussions.
• Experience in biologics, vaccines, rare or autoimmune…