Senior Regulatory Affairs Specialist - Canada (Hybrid)

Elanco; Mississauga; Hybrid; CAD 87,000 - 130,000; Full time

Benefits offered by this job

Hybrid work environment

Health and dental insurance

Holiday closure

Corporate bonus program

Recognition programs

Job summary

Elanco, a global leader in animal health, seeks a Regulatory Affairs Specialist for its Canadian team in Mississauga. You will lead regulatory submissions, manage lifecycle activities, and liaise with authorities to ensure compliant labeling and product information across local and global portfolios.

This role requires a 7+ year track record in Regulatory Affairs, a related science degree, and thorough knowledge of Canadian regulations.

Qualifications

• Bachelor’s or master’s degree in Chemistry, Biochemistry, Microbiology, Pharmacy, or related field.
• At least 7 years of experience in Regulatory Affairs within pharma or animal health.
• Thorough knowledge of Canadian Food and Drugs Act, Food and Drug Regulations, and GMP.
• Knowledge of Canadian frameworks for veterinary biologics, drugs, feed, and pesticides.
• Excellent written and oral communication with ability to coordinate cross-functional teams.

Responsibilities

• Lead preparation and execution of high-quality regulatory submissions for innovation projects, post-approval activities, product variations, and labeling changes.
• Manage relationships with Canadian regulatory authorities, including the Canadian Centre for Veterinary Biologics.
• Coordinate global and local change-control activities and lifecycle management of marketed products.
• Provide regulatory advice to affiliate and launch teams on product registration, regulatory intelligence, labeling strategies, and local advertising requirements.
• Partner with Global Regulatory, Pharmacovigilance, Sales & Marketing, Supply Chain, and Quality teams to deliver compliant regulatory outcomes.

Skills

Regulatory Affairs

Cross-functional collaboration

Regulatory submissions

Canadian regulatory expertise

Excellent communication

Education

Chemistry / Biochemistry / Microbiology / Pharmacy degree

Job description

Elanco, a global leader in animal health, seeks a Regulatory Affairs Specialist for its Canadian team in Mississauga. You will lead regulatory submissions, manage lifecycle activities, and liaise with authorities to ensure compliant labeling and product information across local and global portfolios.

This role requires a 7+ year track record in Regulatory Affairs, a related science degree, and thorough knowledge of Canadian regulations.