Associate Director, Regulatory Strategy, Canada

Moderna; Toronto; On-site; CAD 120,000 - 150,000; Full time

Job summary

A biotechnology company in Toronto is seeking an Associate Director of Regulatory Strategy. You will lead Canadian regulatory submissions and align strategies with global plans. The ideal candidate has over 8 years of experience in regulatory affairs and a deep understanding of Health Canada requirements. This role promotes innovation and collaboration and offers a range of competitive benefits.

Benefits

Quality healthcare and insurance benefits

Free access to fitness classes

Generous paid time off

Qualifications

• 8+ years of progressive Regulatory Affairs experience with significant leadership in Canadian regulatory strategy.
• Expertise in CTD / eCTD formats and Health Canada Module 1 documents.
• Proven track record in major regulatory submissions.

Responsibilities

• Provide regulatory leadership across Canadian filings.
• Drive Canadian regulatory strategy with Global Regulatory Science.
• Oversee preparation and execution of regulatory submissions.

Skills

Regulatory leadership

Cross-functional team influence

Problem-solving skills

Written and oral communication

Education

BA / BS in a scientific / engineering / healthcare discipline

Master’s, PharmD or PhD

Job description

Overview

Associate Director, Regulatory Strategy, Canada role at Moderna. This is a strategic regulatory position focused on Canadian regulatory pathways for Moderna’s mRNA medicines. Based in Toronto, the role involves leading Health Canada submissions and coordinating with global teams to align regulatory plans with development and commercialization efforts.

The Role

Joining Moderna offers the opportunity to be part of a pioneering team revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. You will help shape and operationalize regulatory strategy for Moderna’s mRNA medicines in Canada, lead Health Canada submissions—including CTAs, NDSs, and SNDSs—ensure alignment with global plans, and collaborate with Global Regulatory Science. You will mentor junior staff and engage with Health Canada to enable regulatory success across the product lifecycle. This position is based in Toronto and offers exposure to Canada’s regulatory interface within an innovative, globally collaborative environment.

Responsibilities

• Provide regulatory leadership across Canadian filings, ensuring alignment with cross-functional and global partners.
• Drive Canadian regulatory strategy in collaboration with Global Regulatory Science, integrating local requirements 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 to support successful outcomes and resolve complex issues.
• Mentor junior regulatory professionals, promoting continuous learning and leadership development.

Additional Responsibilities

• 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 development stages—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.

Qualifications

• BA / BS in a scientific / engineering / healthcare discipline required; Master’s, PharmD or PhD preferred.
• 8+ years of progressive Regulatory Affairs experience with significant leadership of Canadian regulatory strategy and submissions.
• Proven leadership capabilities to influence cross-functional teams and represent Regulatory Affairs in senior-level discussions.
• Experience in biologics, vaccines, or autoimmune / rare diseases is strongly preferred.
• In-depth knowledge of Canadian regulations, Health Canada requirements, and agency processes, with ability to navigate complex regulatory pathways.
• Ability to interpret regulations, guidelines, and policy statements (F&D Act, GCP / GMP, PAAB Code, Health Canada policies, ICH guidelines).
• Proven track record in major regulatory submissions (NDSs, SNDSs, CTAs, post-authorization) and Health Canada interactions.
• Expertise in CTD / eCTD formats and Health Canada Module 1 documents (e.g., QOS, CPID, PSEAT, CS : BE).
• Strong written and oral communication skills; ability to influence across organizational levels.
• Experience building proactive regulatory strategies aligned with business objectives and competitive considerations.
• Excellent organizational skills with the ability to manage multiple high-impact projects under tight timelines.
• Advanced problem-solving skills with a proactive approach to compliant, innovative regulatory solutions.
• Minimum 2 years of work authorization required for this role.

Benefits

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts
• Free premium access to fitness, nutrition, and mindfulness classes
• Family planning and adoption benefits
• Generous paid time off, holidays, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown
• Savings and investments
• Location-specific perks and extras

About Moderna

Since 2010, Moderna has aspired to build the leading mRNA technology platform and a world-class team. We aim to give our people a platform to change medicine and the world. We value belonging and strive to care for patients, our employees, the environment, and our communities. Moderna is 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. We support an in-office culture with a 70 / 30 work model to foster innovation, teamwork, and mentorship.

Equal Opportunity

Moderna is an equal opportunity employer and prohibits discrimination in all aspects of employment. We consider qualified applicants regardless of race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or veteran status, genetic information, sexual orientation, marital or familial status, or any other characteristic protected by law. We may require accommodation requests through the Accommodations and Adjustments team at [e-mail].