Associate Director, Regulatory Affairs
On-siteToronto, Ontario, Canada
Job Summary
Provide leadership to the Canadian Regulatory Affairs team, fostering alignment and high-quality execution across multiple priorities. Develop and influence Canadian regulatory strategy in partnership with Global Regulatory Science, ensuring requirements are embedded within global development plans. Lead the planning, preparation, review, and execution of Health Canada submissions, including Clinical Trial Applications, New Drug Submissions, and post-Notice of Compliance filings. Deliver expert regulatory guidance across assigned development programs, proactively identifying risks and driving effective solutions. Serve as the primary regulatory liaison with Health Canada, partnering with senior leadership to navigate complex discussions. Build regulatory capability by mentoring junior professionals and championing strategic thinking to navigate the evolving landscape for mRNA therapeutics.
Required Qualifications
- BA/BS degree in a scientific/engineering/healthcare discipline
- 8+ years of progressively responsible experience in Regulatory Affairs or related field
- significant experience leading Canadian regulatory strategy and submissions
- Demonstrated leadership capabilities with the ability to influence and guide cross-functional teams
- ability to represent Regulatory Affairs in senior-level discussions
- In-depth knowledge of Canadian regulations, Health Canada requirements, and agency processes
- 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)
- 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
- 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
- ability to prioritize and deliver on multiple high-impact projects under tight timelines
- Advanced problem-solving skills
- proactive approach to shaping compliant, innovative regulatory solutions that enable business success
Desired Qualifications
- Master's, PharmD or PhD
- Experience in biologics, vaccines, rare or autoimmune diseases
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