Associate Director, Regulatory Affairs

Moderna; Toronto; On-site; CAD 176,503 - 318,495; Full time

Benefits offered by this job

Healthcare

Well-being programs

Family building benefits

Generous PTO

Equity opportunity

Global benefits

Job summary

Moderna in Toronto is seeking an experienced Regulatory Affairs leader to shape Canada's regulatory strategy for mRNA therapeutics, lead Health Canada submissions, and partner with Global and local teams to accelerate medicines to patients.

You will mentor junior Regulatory Affairs professionals, drive CTD/eCTD documentation, and navigate complex regulatory topics with senior leadership. The role offers influence from CTA through commercialization while embracing digital tools.

Qualifications

• 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 ability to influence cross-functional teams and participate in senior-level discussions.
• Experience in biologics, vaccines, rare or autoimmune diseases strongly preferred.
• Deep knowledge of Canadian regulations, Health Canada requirements, and agency processes.

Responsibilities

• Develop and influence Canadian regulatory strategy with Global Regulatory Science and stakeholders.
• Lead planning, preparation, review, and execution of Health Canada submissions (CTAs, NDSs, SNDSs, post‑NOC, amendments).
• Maintain accountability for successful regulatory outcomes across submission lifecycles.
• Provide strategic regulatory guidance across development programs and anticipate risks.
• Serve as primary regulatory liaison with Health Canada for assigned programs.

Skills

Regulatory strategy

Leadership

Cross-functional

Regulatory submissions

Health Canada

Biologics experience

Education

Bachelor’s degree in science/engineering/healthcare

Master’s degree preferred

Tools

CTD/eCTD tools

Regulatory databases

Job description

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.

Here’s What You’ll Do

• 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.

The key Moderna Mindsets you'll need to succeed in the role:

• 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.

Here’s What You’ll Need (Basic Qualifications)

• 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.

Pay & Benefits

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.

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• 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 a discretionary year‑end shutdown
• Savings and investments to help you plan for the future
• Location‑specific perks and extras

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

The salary range for this role is $125,300.00 - $226,100.00. This range reflects the minimum and maximum base pay we expect to pay for this position based on our current compensation structure. The actual base pay offered to each employee is determined with due diligence, taking into account factors such as relevant experience, skills, qualifications, education, performance, and business requirements.

We regularly review pay ranges and individual compensation to ensure competitiveness with the external market and to maintain internal equity in alignment with our company’s compensation and pay‑transparency principles.

The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or an equity award, subject to applicable plan eligibility criteria and individual performance.

Please note that this information is provided for transparency and compliance purposes. It does not constitute a contractual commitment or guarantee of a specific rate of pay.

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.

Moderna is a smoke‑free, alcohol‑free, and drug‑free work environment.

Moderna is committed to equal opportunity in employment and non‑discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at [e-mail].