Advisor-R&D

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.

• 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.

• 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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