# Associate Director, Regulatory Affairs

Hiring organization: [Moderna](https://career.thegoodapps.co/organizations/moderna)

Canonical page: https://career.thegoodapps.co/jobs/a8166e67-399e-4304-b8df-f438627824fd

Listed on Moderna's own careers site. Applications go to them directly.

- Employment type: full time
- Seniority: Senior
- Salary: 171000 – 189000 CAD per year

## Summary

An experienced regulatory leader will shape mRNA medicine development strategy for Canada, managing Health Canada submissions and serving as the primary agency liaison while mentoring junior staff and championing innovation in regulatory approaches.

_Our summary, not Moderna's wording._

## Skills named

Good Manufacturing Practice (GMP)

## Required

- BA/BS in scientific/engineering/healthcare discipline
- 8+ years progressively responsible regulatory affairs experience
- Significant experience leading Canadian regulatory strategy and submissions
- Demonstrated leadership and cross-functional influence capabilities
- In-depth knowledge of Canadian regulations and Health Canada processes
- Ability to interpret F&DA, GCP/GMP, PAAB Code, Health Canada policies and ICH guidelines
- Track record leading major regulatory submissions and Health Canada interactions
- Expertise in CTD and eCTD submission builds including Module 1 documents
- Ability to build and maintain Health Canada relationships
- Strong written and oral communication skills
- Experience developing regulatory strategies incorporating business objectives
- Exceptional organizational skills managing multiple high-impact projects
- Advanced problem-solving with proactive approach to regulatory solutions

## Nice to have

- Master's, PharmD, or PhD degree
- Experience in biologics, vaccines, rare or autoimmune diseases
- Experience with Generative AI tools for regulatory work

Apply on Moderna's site: https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx/job/Toronto---Canada/Associate-Director--Regulatory-Affairs_R19491