Associate Director, Regulatory Strategy, Canada

**The Role:**Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases.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.Moderna is solidifying its presence in Toronto, Canada's largest city and a hub for biotech innovation. Our Toronto office focuses on commercial operations, ensuring the delivery of our innovative products to the Canadian market. We're inviting international talents to join our mission of transforming medicine and impacting lives worldwide.This is a strategically critical role for a forward-thinking regulatory professional with deep expertise in Canadian regulatory pathways. As Associate Director of Regulatory Strategy, you will help shape and operationalize regulatory strategy for Moderna’s mRNA medicines in Canada. You’ll lead and manage Health Canada submissions—including CTAs, NDSs, and SNDSs—ensuring alignment with global plans while also anticipating and responding to the regulatory challenges of an entirely new drug modality. You will collaborate cross-functionally with Global Regulatory Science, mentor junior staff, and engage directly with Health Canada to enable regulatory success across the product lifecycle. Based in Toronto, this role offers the opportunity to be at the forefront of Canada's regulatory interface in an environment rich with innovation, autonomy, and global collaboration.**Here’s What You’ll Do:****Your key responsibilities will be:*** Provide regulatory leadership across Canadian filings, ensuring alignment with cross-functional and global partners.* Drive Canadian regulatory strategy in collaboration with Global Regulatory Science, ensuring local requirements and objectives are fully integrated into development and commercialization efforts.* Oversee preparation and execution of regulatory submissions including CTAs, NDSs, SNDSs, post-NOC submissions, and Health Canada meeting packages.* Serve as primary liaison with Health Canada for assigned projects, engaging effectively to support successful outcomes and resolution of complex issues.* Mentor junior regulatory professionals, promoting continuous learning and leadership development.**Your responsibilities will also include:*** Maintain strategic oversight of regulatory labeling activities (Product Monographs, packaging), ensuring alignment with global positioning and compliance.* Lead regulatory intelligence gathering and competitive landscape assessments to anticipate opportunities and risks.* Shape regulatory engagement strategy for projects at all stages of development—from clinical through to commercial.* Foster strong internal collaboration to ensure regulatory deliverables align with broader Canadian and global objectives.* Contribute to a forward-looking regulatory culture that proactively engages with Health Canada and positions Moderna as a leader in regulatory innovation.**The key Moderna Mindsets you’ll need to succeed in the role:*** **“We digitize everywhere possible using the power of code to maximize our impact on patients.”** You will embrace digital tools and platforms—including the potential integration of Generative AI—across regulatory workflows to streamline submissions, enhance intelligence gathering, and ensure strategic agility.* **“We behave like owners. The solutions we’re building go beyond any job description.”** This role requires a proactive leader who sees beyond the immediate task, taking full ownership of regulatory outcomes while mentoring colleagues and enhancing the entire regulatory function in Canada.**Here’s What You’ll Bring to the Table:*** 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 diseases is 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 (Pharmaceutical Advertising Advisory Board) 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 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 the 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 the 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.* As part of Moderna’s commitment to build a sustainable workforce, a minimum of 2 years of work authorization is required for this role.**At Moderna, we believe that when you feel your best, you can do your best work. That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.*** Quality healthcare and insurance benefits* Lifestyle Spending Accounts to create your own pathway to well-being* Free premium access to fitness, nutrition, and mindfulness classes* Family planning and adoption benefits* Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown* Savings and investments* Location-specific perks and extrasThe benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.**About Moderna**Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration
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