Responsibilities:
1. Lead the design and development of regulatory strategy and technical documents in support of global development projects.
2. Manage resources and provide technical leadership to ensure timely delivery of regulatory activities and compliance.
3. Represent the regulatory viewpoint on development teams and lead engagements with regulatory agencies in the EU or the USA.
4. Develop and maintain effective relationships with global regulatory authorities and influence industry associations.
5. Proactively identify and communicate project-specific risks and opportunities to internal stakeholders.
What You Need to Succeed (minimum qualifications):
6. Master’s degree or higher in veterinary medicine, biologic, infectious diseases, immunology, or a related field.
7. A minimum of 10 years of experience in the animal health industry, with direct Regulatory Affairs experience with biologics/large molecule products.
8. 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):
9. Master's degree in Life Sciences or Management.
10. Broad knowledge covering obtaining licenses in different geographies.
11. Experience working with novel regulatory pathways or mechanisms.
12. Strong interpersonal and communication skills with the ability to influence and diplomatically challenge.
13. 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!