Associate Director, Regulatory Affairs

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. This is an opportunity for an experienced regulatory leader to help shape the future of mRNA therapeutics in Canada.

Responsibilities

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

Requirements

BA/BS degree in a scientific/engineering/healthcare discipline required; 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 represent Regulatory Affairs in senior-level discussions; 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 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 Canada-specific Module 1 documents (e.g., QOS, CPID, PSEAT, CS:BE); Demonstrated success building and maintaining Health Canada relationships, including negotiating on complex regulatory topics; Strong written and oral communication skills with ability to influence across levels of the organization; Experience developing and executing proactive regulatory strategies that incorporate business objectives and competitive considerations; Exceptional organizational skills with ability to prioritize and deliver on multiple high-impact projects under tight timelines; Advanced problem-solving skills with a proactive approach to shaping compliant, innovative regulatory solutions that enable business success

Nice to have

Master's, PharmD or PhD preferred; Experience in biologics, vaccines, rare or autoimmune diseases is strongly preferred

Benefits

Competitive healthcare, plus voluntary benefit programs; A holistic approach to well-being with access to fitness, mindfulness, and mental health support; Family building benefits, including fertility, adoption, and surrogacy support; Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown; Savings and investments to help you plan for the future; Location-specific perks and extras; Annual discretionary bonus, other incentive compensation, or equity award