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:
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.
Your responsibilities:
- 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
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.
Advisor-R&D in Liverpool employer: Elanco
Elanco is an excellent employer that champions a diverse and inclusive workplace culture, making it an ideal environment for professionals seeking to make a meaningful impact in the field of quality control. Located in Liverpool, employees benefit from a collaborative atmosphere that encourages continuous improvement and offers ample opportunities for personal and professional growth, alongside the chance to engage in strategic initiatives across a global laboratory network.
