Regulatory Affairs Specialist

CA01 Elanco Canada Limited; 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

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. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.

Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose™ CSR framework - all to advance the health of animals, people and the planet. Learn more at www.elanco.com.