Senior Associate - Regulatory CMC, Biocides/Pesticides/Topicals/Collars (m/f/d)

In this role you will shape global regulatory CMC strategy for veterinary biocides, pesticides and topical products, author submissions, and oversee lifecycle management from development through approval and renewals. You’ll collaborate with R&D, Manufacturing and Quality, plus global regulatory teams, to ensure compliant registrations across regions. You will lead pre-submission planning and clearly communicate strategy and issues to cross-functional teams. This position enables geo-expansion and impactful contributions to animal health products at Elanco.

• Oversee end-to-end lifecycle management of pharmaceutical dosage forms (e.g., otic solutions/suspensions, spot-on, pour-on, collars)
• Design/develop CMC regulatory strategy for geo-expansion with focus on innovation and regulatory compliance
• Maintain positive collaboration with R&D, Quality, Manufacturing and global regulatory partners
• Lead CMC pre-submission preparation and proactively communicate regulatory strategy, issues, and timelines across project teams
• Ensure documentation and content, quality and timelines for global submissions are communicated and tracked
• Author high-quality CMC documentation for submissions and provide training/mentorship to CMC team members

• Degree in Science
• Min. 5 years in Global Regulatory Affairs, CMC
• Strong knowledge of FDA (CVM), EPA, EMA and ICH/VICH guidelines
• Experience in developing CMC Regulatory Strategy for topical dosage forms for US, Europe, and other regions
• Understanding of cGMP requirements (21 CFR Parts 210 & 211)
• Strong written and verbal communication
• Decision-making ability under ambiguity
• Strong organizational skills and ability to manage multiple projects
• Fluency in English and good German skills

• Strong communication skills
• Decision-making ability
• Organizational skills
• CMC regulatory strategy
• Global regulatory submissions
• Lifecycle management of pharmaceutical dosage forms