Associate Director, Regulatory Strategy, Canada

The Role:

Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases.

As an employee youll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide contributing to global health initiatives.

Modernas 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 Canadas 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. Were 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 Modernas mRNA medicines in Canada. Youll lead and manage Health Canada submissionsincluding CTAs NDSs and SNDSsensuring 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 Canadas regulatory interface in an environment rich with innovation autonomy and global collaboration.

Heres What Youll 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 developmentfrom 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 youll 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 platformsincluding the potential integration of Generative AIacross regulatory workflows to streamline submissions enhance intelligence gathering and ensure strategic agility.

• We behave like owners. The solutions were 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.

Heres What Youll Bring to the Table:

• BA/BS degree in a scientific/engineering/healthcare discipline required Masters 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 Canadaspecific 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 Modernas 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. Thats why our global benefits and well-being resources are designed to support youat 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
• Savingsandinvestments
• 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.

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 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 by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation teamwork and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.

If you want to make a difference and join a team that is changing the future of medicine we invite you to visit to learn more about our current opportunities.

Moderna is a smoke-free alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day please apply!

Moderna is committed to equal opportunity in employment and non-discrimination for all employees and qualified applicants without regard to a persons 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.

Were 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 .