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.

• Provide leadership to the Canadian Regulatory Affairs team, fostering alignment, accountability, collaboration, 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.

• 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 a 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 diseases strongly preferred.
• In‑depth knowledge of Canadian regulations, Health Canada requirements, and agency processes, with proven ability to navigate complex regulatory pathways.
• Proven ability to interpret regulations, guidelines and policy statements, including Food & Drugs Act and Regulations (F&DA), Good Clinical Practice and Good Manufacturing Practices (GCP/GMP), PAAB Code of Advertising Acceptance, Health Canada policies, guidelines, and forms; ICH guidelines.
• Proven track record of leading the preparation, review, and execution of major regulatory submissions (NDSs, SNDSs, CTAs, post‑authorization) and successful Health Canada interactions.
• Expertise in CTD format and eCTD submission builds, including authoring and reviewing Health…