Advisor-R&D
On-siteSpeke, England, United Kingdom
Job Summary
Develop global CMC regulatory strategies for post-approval changes and market expansion for veterinary biological products. Lead CMC regulatory activities and submission strategies while authoring high-quality documentation for global submissions. Collaborate with cross-functional teams across R&D, Manufacturing, Quality, and Regulatory Affairs to deliver successful regulatory outcomes. Monitor evolving regulatory requirements and translate them into business strategy to drive regulatory excellence and ensure compliance across global markets. This Advisor-R&D role focuses on shaping global regulatory strategies for biologicals and vaccines within the Global Regulatory Affairs team at Elanco.
Required 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
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