Elanco

Senior Regulatory Affairs Manager

Elanco  •  Hook, GB (Onsite)  •  20 days ago
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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: Senior Regulatory Affairs Manager

As a Senior Regulatory Affairs Manager, you will be part of the global regulatory team to deliver pre-approval and life cycle management for development projects. In this role, you will be responsible for advancing the regulatory strategy for innovation projects across key countries, working collaboratively with Global R&D, Sales and Marketing, Supply Chain, and other key stakeholders.

Your Responsibilities:

  • Lead the design and development of regulatory strategy and technical documents in support of global development projects.
  • Manage resources and provide technical leadership to ensure timely delivery of regulatory activities and compliance.
  • Represent the regulatory viewpoint on development teams and lead engagements with regulatory agencies in the EU or the USA.
  • Develop and maintain effective relationships with global regulatory authorities and influence industry associations.
  • Proactively identify and communicate project-specific risks and opportunities to internal stakeholders.

What You Need to Succeed (minimum qualifications):

  • Master’s degree or higher in veterinary medicine, biologic, infectious diseases, immunology, or a related field.
  • A minimum of 10 years of experience in the animal health industry, with direct Regulatory Affairs experience with biologics/large molecule products.
  • Demonstrated regulatory leadership and dossier registration experience, alongside a strong understanding of global regulatory procedures and risk assessment fundamentals.

What will give you a competitive edge (preferred qualifications):

  • Master's degree in Life Sciences or Management.
  • Broad knowledge covering obtaining licenses in different geographies.
  • Experience working with novel regulatory pathways or mechanisms.
  • Strong interpersonal and communication skills with the ability to influence and diplomatically challenge.
  • Fluent in English.

Additional Information:

Travel: 10-25% annually

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

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.

Elanco

About Elanco

At Elanco, we are united by a genuine love and care for animals. Our purpose - making life better for animals, makes life better - fuels us to break boundaries and inspires us to push further, transforming animal care, going beyond to improve outcomes for animals, customers, and society to create a better, more sustainable world. We are veterinarians, pet owners, farmer’s kids and animal lovers. Our team doesn’t just work in the animal health industry - we live it.

By putting customers’ needs at the center of everything we do, our comprehensive portfolios of trusted brands and focused pipeline are transforming the future of animal care. From developing the first treatment for one of the deadliest diseases in puppies to removing needles from diabetes care to pioneering new sustainable market spaces for farmers, we're raising the bar and making a difference - for animals, for our customers and their business.

Industry
Chemicals & Materials
Company Size
5,001-10,000 employees
Headquarters
Indianapolis, IN
Year Founded
Unknown
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