Global Regulatory Project Lead - Global Regulatory Affairs

Elanco Tiergesundheit AG; Hook; On-site; GBP 90,000 - 130,000; Full time

Benefits offered by this job

Travel 10-25%

Job summary

Elanco is seeking a Global Regulatory Project Lead to drive regulatory strategy and life cycle management for development projects on a global scale. You will collaborate with Global R&D, Sales, Marketing, and Supply Chain to deliver pre-approval and life cycle activities.

The role requires a Master’s degree or higher in veterinary or related field, 10+ years in animal health regulatory affairs, and proven leadership in regulatory submissions across geographies including EU and USA.

Qualifications

• Master’s degree or higher in veterinary medicine, biologic, infectious diseases, immunology, or a related field.
• 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, with a strong understanding of global regulatory procedures and risk assessment fundamentals.

Responsibilities

• Lead regulatory strategy and development of technical documents for global development projects.
• Manage resources and provide technical leadership to ensure timely regulatory activities and compliance.
• Represent regulatory viewpoint on development teams and lead engagements with EU/USA regulatory agencies.

Skills

Regulatory leadership

Dossier registration

Global regulatory procedures

Stakeholder management

English fluency

Education

Master's degree or higher in veterinary medicine or related field

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: Global Regulatory Project Lead - Global Regulatory Affairs

As a Global Regulatory Project Lead, 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 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.