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. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals’ lives better makes life better – join our team today!
Your Role:
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.
Your 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.
What You Need to Succeed (minimum qualifications):
- 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.
What will give you a competitive edge (preferred qualifications):
- 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.
Additional Information:
Travel: Up to 10%
Location: Mississauga, Ontario, Canada
Work model: Hybrid work environment
Elanco Benefits and Perks:
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
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
Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.
Skills Required
- Bachelor’s or master’s degree in Chemistry, Biochemistry, Microbiology, Pharmacy, or a related scientific discipline
- At least 7 years of Regulatory Affairs experience in the pharmaceutical or animal health industry
- Thorough knowledge of the Canadian Food and Drugs Act, Food and Drug Regulations, and Good Manufacturing Practice Regulations
- Thorough knowledge of Canadian regulatory frameworks governing veterinary biologics, drugs, feed, and pesticides
- Excellent written and oral communication skills
- Ability to coordinate cross-functional teams and represent the company in interactions with regulatory authorities
- Strong attention to detail in technical documentation
- Experience in the animal health industry
- Experience managing submissions through the Canadian Centre for Veterinary Biologics
- Experience with emerging biotechnological platforms or biotechnology-related regulatory submissions
- Ability to lead complex regulatory projects from inception to completion, identify risks, and raise concerns early
- Experience applying innovative thinking to complex regulatory challenges and driving continuous improvement
Elanco Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Elanco and has not been reviewed or approved by Elanco.
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Leave & Time Off Breadth — Time off options are broad, including PTO, flexible leave, and the ability to purchase additional vacation. These provisions are highlighted as supportive of work-life balance.
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Healthcare Strength — Health coverage includes medical, dental, and vision alongside company-paid life, disability, and wellness support. Pet insurance and assistance programs reinforce a comprehensive wellbeing offering.
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Retirement Support — Retirement offerings include a U.S. 401(k) and, for some employees, access to a defined benefit pension. These programs add meaningful long-term value to total rewards.
Elanco Insights
What We Do
At Elanco, we work to improve the health of animals through innovative products and services for pets and farm animals around the world. As a global animal health company, we provide solutions that empower our customers to advance a vision of Food and Companionship Enriching Life. Since 1954, Elanco has committed to empowering veterinarians, farmers, and all those who care for animals with the tools they need to help animals live healthy lives. Healthier animals are the key to making our lives better - This is the fundamental belief uniting all global Elanco employees. That’s why we are committed to the idea that our business can be a unique force for good for all in society. Through our Elanco Healthy Purpose™ framework of Environmental, Social and Governance (ESG) commitments, we focus on delivering sustainable solutions to advance the well-being of animals, people and the planet. This program also enables our employees around the world to take paid time off to make an impact as a volunteer, offering their time or talent to give back to our customers, causes and communities. #ElancoHealthyPurpose #WeAreElanco
