Canada Regulatory Affairs Specialist – Impact & Compliance

429 Eli Lilly Canada Inc.; Toronto; On-site; CAD 65,000 - 147,000; Full time

Benefits offered by this job

Bonus program

Pension plan

Health benefits

Vacation benefits

Flexible benefits

Life insurance

Paid time off

Job summary

Lilly Canada is seeking a Regulatory Associate/Sr Regulatory Associate/Manager for the Greater Toronto Area. The role focuses on executing regulatory plans for new registrations, line extensions, and indications, with on-site presence about 10 days per month.

Minimum requirements include a Bachelor’s in a relevant science and 1–3 years in regulatory affairs, plus strong communication and project management skills. English/French bilingual is a plus.

Qualifications

• Bachelor’s degree or equivalent in a relevant scientific subject.
• 1–3 years of regulatory affairs experience with external regulators and health-care system.
• Good computer/IT skills; ability to navigate regulatory IT tools.

Responsibilities

• Regulatory Plan Execution and timely submission of regulatory applications.
• Maintain marketing authorisations including renewals and variations.
• Support Health Canada submissions and alignment with local regulations.
• Collaborate with cross-functional teams and external regulatory agencies.
• Provide regulatory input to launch readiness and product planning.

Skills

Team working

Analytical skills

Negotiation skills

Communication skills

Project management

Planning & priority setting

Quality systems knowledge

Bilingual English/French

Education

Bachelor’s degree in a relevant scientific subject

Tools

IT skills

Job description

Lilly Canada is seeking a Regulatory Associate/Sr Regulatory Associate/Manager for the Greater Toronto Area. The role focuses on executing regulatory plans for new registrations, line extensions, and indications, with on-site presence about 10 days per month.

Minimum requirements include a Bachelor’s in a relevant science and 1–3 years in regulatory affairs, plus strong communication and project management skills. English/French bilingual is a plus.