Advisor-R&D

Overview

In this role, you will develop and oversee global CMC regulatory strategies for veterinary biological products, guiding post-approval changes and market expansion. You will partner with R&D, Manufacturing, Quality and Regulatory Affairs to ensure compliant submissions and regulatory outcomes across worldwide markets. You’ll monitor evolving rules, translate them into business strategy, and drive regulatory excellence in a global environment. This is a chance to influence how vaccines and biological products reach animals and their communities.

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 regulatory outcomes
• Monitor evolving regulatory requirements and translate them into business strategy
• Drive regulatory excellence and ensure compliance across global markets

Key requirements

• 8+ years of Global Regulatory Affairs experience within biologicals, vaccines, biotechnology or CMC
• Bachelor's degree in a scientific discipline
• 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

• Stakeholder management
• Strong written and verbal communication
• Influence in a cross-functional, global matrix
• CMC regulatory strategy
• Global regulatory submissions
• Regulatory monitoring and interpretation

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