International Regulatory Specialist - Medical Devices (Remote) (Northwest Territories)

International Regulatory Specialist - Medical Devices (Remote) (Northwest Territories)

03 Oct
|
Elanco
|
Northwest Territories

03 Oct

Elanco

Northwest Territories

At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Making animals’ lives better makes life better – join our team today!

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. 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. 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 Valuable 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 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.

Travel: Up to 10% Competitive Corporate Bonus program Comprehensive health and dental insurance plan options Holiday closure Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice. #

📌 International Regulatory Specialist - Medical Devices (Remote) (Northwest Territories)
🏢 Elanco
📍 Northwest Territories

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