Advisor – Global Regulatory Affairs CMC Biologicals

In this role you will shape global CMC regulatory strategies for veterinary biologics, supporting geo-expansion and post-approval changes. You collaborate across R&D, Manufacturing, Quality and regulatory partners to enable registrations and timely submissions. You will lead pre-submission activities, communicate strategic CMC considerations, and author high-quality regulatory documentation. The role keeps you ahead of evolving guidelines and industry trends, driving compliant, impactful submissions worldwide. Join a mission-driven team advancing animal health through innovation and cross-functional partnership.

• Design and develop regulatory CMC strategy for post-approval changes and geo-expansion of marketed biological products
• Maintain positive collaboration with internal groups (R&D, Manufacturing, Quality, global regulatory partners)
• Lead CMC regulatory pre-submission preparation and communicate strategy to interdisciplinary teams throughout the product life cycle
• Ensure documentation and timelines for global submissions are tracked and communicated to the appropriate teams
• Author high-quality CMC regulatory documentation for submissions
• Stay abreast of changing regulatory guidelines and industry trends and share insights internally

• Bachelor of Science
• Excellent understanding of EU regulatory legislation for veterinary vaccines
• Fluent in English and German
• 8+ years in Global Regulatory Affairs (preferably vaccines/biotech/CMC)
• Experience in developing regulatory CMC strategy for Europe (EMA) and other regions
• Excellent scientific writing and communication skills
• Strong planning and organizational skills
• Flexibility and adaptability to new technologies
• Ability to work cross-functionally and influence decisions in a matrix environment

• communication skills
• cross-functional collaboration
• adaptability
• CMC regulatory strategy
• global regulatory submissions
• regulatory guidelines awareness