Advisor-R&D

Are you an experienced CMC Regulatory Affairs professional with a passion for biologicals and veterinary vaccines? Do you enjoy shaping global regulatory strategies and collaborating with cross-functional teams to bring innovative products to markets worldwide?

We're looking for an Advisor - Global Regulatory Affairs CMC Biologicals to join our Global Regulatory Affairs team.

As part of our global team, you'll play a key role in developing and executing CMC regulatory strategies for veterinary biological products throughout their lifecycle. You'll work closely with colleagues across R&D, Manufacturing, Quality and Regulatory Affairs to support post-approval changes, global registrations and international market expansion.

• →Developing global CMC regulatory strategies for post-approval changes and market expansion
• →Leading CMC regulatory activities and submission strategies for biological products
• →Authoring high-quality CMC regulatory documentation for global submissions
• →Collaborating with cross-functional teams to deliver successful regulatory outcomes
• →Monitoring evolving regulatory requirements and translating them into business strategy
• →Driving regulatory excellence while ensuring compliance across global markets

What You Need to Succeed (minimum qualifications): 

• →Bachelor's degree in a scientific discipline
• →8+ years of Global Regulatory Affairs experience within biologicals, vaccines, biotechnology or CMC
• →Strong knowledge of EU veterinary vaccine regulations (EMA)
• →Experience developing global CMC regulatory strategies for Europe and international markets
• →Excellent scientific writing, communication and stakeholder management skills
• →Ability to influence cross-functional teams in a global matrix environment
• →Fluent English

Don’t meet every single requirement? Studies have shown underrepresented 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.