Regulatory Affairs Specialist

About This Role

This role supports the registration and lifecycle management of products across a diverse animal-health portfolio as a key member of Elanco's Canadian Regulatory Affairs team. The specialist will lead regulatory submissions, develop labelling strategies, prepare dossiers, and engage with Canadian regulatory authorities, helping to ensure compliance and consistency across global and local product information.

Responsibilities

• Lead the preparation and execution of high-quality regulatory submissions for innovation projects, post-approval activities, product variations, and labelling changes
• Manage relationships with Canadian regulatory authorities, including the Canadian Centre for Veterinary Biologics, and support the regulatory relationship management strategy for the Canadian business
• Coordinate global and local change-control activities, ensuring timely submission of variations and effective lifecycle management of marketed products
• Provide regulatory advice to the Canadian affiliate and launch teams on product registration, regulatory intelligence, labelling strategies, and local advertising requirements for promotional materials
• Partner with Global Regulatory, Pharmacovigilance, Sales and Marketing, Supply Chain, and Quality teams to deliver compliant regulatory outcomes across multiple projects and timelines

Requirements

• Bachelor's or master's degree in Chemistry, Biochemistry, Microbiology, Pharmacy, or a related scientific discipline
• At least 7 years of experience in Regulatory Affairs within the pharmaceutical or animal health industry
• Thorough knowledge of the Canadian Food and Drugs Act, Food and Drug Regulations, and Good Manufacturing Practice (GMP) Regulations
• Thorough knowledge of the Canadian regulatory frameworks governing veterinary biologics, drugs, feed, and pesticides
• Excellent written and oral communication skills, with the ability to coordinate cross-functional teams, represent Elanco in interactions with competent authorities, and maintain strong attention to detail in technical documentation

Nice to have:

• Experience in Animal health industry
• Experience managing submissions through the Canadian Centre for Veterinary Biologics
• Experience working with emerging biotechnological platforms or biotechnology-related regulatory submissions
• Demonstrated ability to lead complex regulatory projects from inception to completion while identifying risks and raising concerns early
• A track record of applying innovative thinking to complex regulatory challenges and driving continuous improvement

Benefits

• Competitive Corporate Bonus program
• Comprehensive health and dental insurance plan options