At a Glance
- Tasks: Develop and execute regulatory strategies for veterinary biological products.
- Company: Join a leading company in global regulatory affairs with a focus on innovation.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Dynamic work environment with a commitment to diversity and inclusion.
- Why this job: Make a real impact in the veterinary field while working with cross-functional teams.
- Qualifications: Bachelor’s degree in science and 8+ years in Global Regulatory Affairs.
The predicted salary is between 63000 - 77000 £ per year.
Role Overview
Advisor – Global Regulatory Affairs CMC Biologicals.
Responsible for developing and executing CMC regulatory strategies for veterinary biological products across the product lifecycle, cooperating with R&D, Manufacturing, Quality, and Regulatory Affairs.
Responsibilities
- Develop global CMC regulatory strategies for post‑approval changes and market expansion.
- Lead CMC regulatory activities and submission strategies for biological products.
- Author high‑quality CMC regulatory documentation for global submissions.
- Collaborate with cross‑functional teams to deliver successful regulatory outcomes.
- Monitor evolving regulatory requirements and translate them into business strategy.
- Drive regulatory excellence while ensuring compliance across global markets.
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.
EEO Statement
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 to support parts of our recruitment process, but all hiring decisions involve a human reviewer.
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Advisor-R&D in Liverpool employer: Elanco Tiergesundheit AG
Elanco Tiergesundheit AG is an excellent employer that fosters a culture of diversity and innovation, making it a rewarding place to work for those passionate about animal health. With a strong emphasis on employee growth and development, the company offers comprehensive training opportunities and a supportive environment that encourages collaboration and excellence. Located in the UK, Elanco provides a unique chance to contribute to meaningful projects while enjoying a balanced work-life dynamic.
