(Senior) Regulatory Affairs Manager, EU Procedures

GB01 Elanco UK AH Limited; Hook; Hybrid; GBP 60,000 - 90,000; Full time

Benefits offered by this job

None

Job summary

Elanco is seeking a (Senior) Regulatory Affairs Manager, EU Procedures, to support regional registration activities for existing animal health products across EU and the United Kingdom.

You will coordinate regulatory submissions, product labelling activities and post-approval commitments while partnering with affiliates, global teams and regulatory authorities to maintain marketing authorisations and support continued product supply.

Qualifications

• Bachelor’s or Master’s degree in veterinary medicine, biologic, infectious diseases, immunology, or a related field.
• 2+ years of experience in regulatory affairs.
• Fluent English.
• Ability to prepare and deliver complete, high-quality technical submission packages to competent authorities.
• Experience coordinating submission components such as national requirements, translations, fee payments and dossier publication.

Responsibilities

• Coordinate the planning, preparation, publication and delivery of high-quality technical submission packages for European Union and United Kingdom regulatory procedures.
• Manage regulatory submission timelines, tracking and prioritisation for innovation and established products using Vault RIM, ensuring critical milestones are delivered on time.
• Partner with European affiliates, Marketing, Research and Development and other relevant functions to complete national requirements, maintain product labelling and support product compliance.
• Act as a point of contact for regulatory authorities and support the preparation and execution of authority meetings, questions and responses, as well as post-approval commitments.
• Monitor changes in legislation and regulatory guidance, assess their business impact and contribute to process improvements, regulatory advocacy and effective project and budget forecasting.

Skills

Fluent English

Interpersonal skills

Communication skills

Education

Bachelor’s or Master’s degree in veterinary medicine/biologic/infectious diseases/immunology

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, EU Procedures

As a (Senior) Regulatory Affairs Manager, EU Procedures, you will support regional registration activities for existing animal health products registered in two or more European Economic Area countries or the United Kingdom. You will coordinate regulatory submissions, product labelling activities and post-approval commitments while partnering with affiliates, global teams and regulatory authorities to maintain marketing authorisations and support continued product supply.

Your Responsibilities:

• Coordinate the planning, preparation, publication and delivery of high-quality technical submission packages for European Union and United Kingdom regulatory procedures.
• Manage regulatory submission timelines, tracking and prioritisation for innovation and established products using Vault RIM, ensuring critical milestones are delivered on time.
• Partner with European affiliates, Marketing, Research and Development and other relevant functions to complete national requirements, maintain product labelling and support product compliance.
• Act as a point of contact for regulatory authorities and support the preparation and execution of authority meetings, questions and responses, as well as post-approval commitments.
• Monitor changes in legislation and regulatory guidance, assess their business impact and contribute to process improvements, regulatory advocacy and effective project and budget forecasting.

What You Need to Succeed (minimum qualifications):

• Education: Bachelor’s or Master’s degree in veterinary medicine, biologic, infectious diseases, immunology, or a related field.
• 2+ years of experience in regulatory affairs.
• Fluent English.
• Ability to prepare and deliver complete, high-quality technical submission packages to competent authorities.
• Experience coordinating submission components such as national requirements, translations, fee payments and dossier publication.

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

• Experience in the animal health industry.
• Experience working with cross-functional and international teams across regulatory, Research and Development, Marketing and affiliate organisations.
• Strong interpersonal and communication skills.

Additional Information:

• Travel: Around 10%.
• Work model: Hybrid.
• Location: The role can be based in the UK - Hook, Germany - Bad Homburg, Belgium -Antwerp or Netherlands - Utrecht.

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!

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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 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.