Regulatory Affairs Specialist at Elanco in CA - Mississauga

Job description

• As a Regulatory Affairs Specialist, you will be a key member of Elanco’s Canadian Regulatory Affairs team, supporting the registration and lifecycle management of products across a diverse animal-health portfolio. You will lead regulatory submissions, develop labelling strategies, prepare dossiers, engage with Canadian regulatory authorities, and help 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.
• 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.

Skills

Preferred

• Experience in Animal health industry

Benefits

• ​The expected base salary for this position ranges from $86,700 to $130,000. The actual base salary offered may vary based on the successful candidate’s qualifications, including education and experience. Additionally, Elanco offers a comprehensive benefit program to eligible employees. The compensation package is subject to change, and the actual base salary could be higher or lower than the range described above.
• Competitive Corporate Bonus program
• Comprehensive health and dental insurance plan options
• Holiday closure
• High value recognition programs