Associate Director, Regulatory Affairs (mRNA Therapeutics)

Location: Toronto, Canada; 70% in-office work model

Salary: $171,000.00–$189,000.00 annual base pay, plus potential discretionary bonus, incentive compensation, or equity award.

Company

hirify.global develops mRNA medicines and a technology platform focused on transforming how medicines are created and delivered.

What you will do

• Develop Canadian regulatory strategy in partnership with Global Regulatory Science and cross-functional stakeholders.
• Lead the planning, preparation, review, and execution of Health Canada submissions, including CTAs, NDSs, SNDSs, amendments, supplements, and post-NOC submissions.
• Provide strategic oversight throughout submission lifecycles and guide development programs from clinical trials through commercialization.
• Serve as the primary regulatory liaison with Health Canada and support complex agency interactions and negotiations.
• Lead Canadian labelling activities, including Product Monographs and packaging.
• Mentor Regulatory Affairs professionals and lead regulatory intelligence, strategic planning, and continuous improvement initiatives.

Requirements

• BA/BS degree in a scientific, engineering, or healthcare discipline required; a Master’s, PharmD, or PhD is preferred.
• 8+ years of progressively responsible Regulatory Affairs or related experience, including Canadian regulatory strategy and submissions.
• In-depth knowledge of Canadian regulations, Health Canada requirements, agency processes, and complex regulatory pathways.
• Experience with major submissions, CTD format, eCTD builds, and Health Canada-specific Module 1 documents.
• Knowledge of the Food & Drugs Act and Regulations, GCP, GMP, PAAB Code, Health Canada policies and guidelines, and ICH guidelines.
• Strong leadership, communication, organizational, problem-solving, and cross-functional influencing skills.

Nice to have

• Experience in biologics, vaccines, rare diseases, or autoimmune diseases.
• Master’s degree, PharmD, or PhD.

Culture & Benefits

• In-person collaboration supported by a 70/30 work model.
• Healthcare and voluntary benefit programs, plus fitness, mindfulness, and mental health resources.
• Family-building support covering fertility, adoption, and surrogacy.
• Paid vacation, bank holidays, volunteer days, sabbatical, recharge days, and year-end shutdown.
• Savings and investment programs, with additional location-specific benefits.
• Artificial intelligence is used to screen, assess, or select applicants for this role.