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: Senior Regulatory Affairs Manager
As the Senior Regulatory Affairs Manager, you will be responsible for leading registration projects and regulatory activities to ensure compliance with local laws, regulations, and Elanco’s internal policies and SOPs. This includes managing product registrations, license renewals, product variations, and marketing authorization transfers, while also supporting regulatory strategy and cross-functional collaboration to ensure product availability and compliance.
Your Responsibilities:
Lead the development and execution of regulatory strategies and coordinate resources for timely, high-quality submissions.
Prepare and deliver regulatory submissions for new product registrations, renewals, and variations.
Coordinate with internal Elanco systems (e.g., Vault RIM, BLUE, Vault Clinical) to support registration processes.
Liaise with regulatory authorities on product registration activities, inquiries, and reviews, including sample testing.
Monitor and report adverse events (AE) and product complaints (PC) in compliance with Elanco SOPs and local/global regulatory requirements.
Maintain accurate and up-to-date regulatory and legal documentation (licenses, certificates, etc.).
Provide local regulatory expertise and scientific input to support global product development and R&D teams.
Collaborate with cross-functional teams (Quality, Supply Chain, and Regional Support) to minimize regulatory-related supply disruptions.
Review and approve promotional materials for regulatory compliance (Vault PromoMats).
Support Quality Affairs projects and ensure alignment with regulatory requirements (Vault Quality).
Participate in government affairs initiatives (e.g., CODEX, AMR policy) and key regulatory authority meetings to support affiliate strategy and compliance.
Contribute regulatory insights to affiliate strategy, policies, and market access initiatives.
Coordinate local development and post-marketing studies where applicable.
Ensure full compliance with Elanco’s Code of Conduct, Ethics and Compliance standards, and external regulations.
What You Need to Succeed (Minimum Qualifications):
Education: Bachelor’s degree (or higher) in Veterinary Science, Pharmacy, Biology, or a related field.
Experience: Minimum of 5–8 years in Regulatory Affairs within the pharmaceutical, veterinary, or animal health industry.
Skills:
Strong understanding of local regulatory requirements and registration processes.
Excellent communication and collaboration skills across internal and external stakeholders.
Proficiency in documentation systems and regulatory databases (e.g., Vault, BLUE).
What Will Give You a Competitive Edge (Preferred Qualifications):
Experience engaging with the Ministry of Agriculture or other government regulatory bodies.
Knowledge of animal health products, including vaccines, feed additives, or pharmaceuticals.
Proven track record managing license renewals, site transfers, or manufacturing changes.
Strong analytical, strategic thinking, and project management skills.
Familiarity with global regulatory systems and multi-country registration coordination.
Additional Information:
Don’t meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
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
