Regulatory Affairs Officer

• Maintain marketing authorizations in various regions, focusing on the EU region
• Prepare regulatory submissions, mainly variations for an upcoming manufacturing line transfer
• Write and update the quality part of the regulatory dossier (part 2/module 3)
• Respond to questions from regulatory authorities
• Ensure regulatory compliance of veterinary medicine product information and quality dossiers
• Collaborate with Regulatory Affairs, Quality Assurance, R&D, and Manufacturing teams
• Submit and monitor change requests following approval of variations or other regulatory activities
• Verify artwork and promotional materials for the French market
• Support the growth and expansion of Orion Animal Health in veterinary medicinal products

Requirements

• A degree in chemistry, life sciences, or a related field (e.g., laboratory techniques, biology, biomedical sciences)
• Experience with CMC (module 3 or part 2) dossier writing is required
• First experience in regulatory affairs for human or veterinary medicines would be beneficial
• Fluency in English and French
• Strong team player with excellent planning and accuracy skills
• Ability to collaborate with people from various countries and cultures
• Valid work permit for France
• Approved medical examination, including drug testing, required prior to employment
• Security clearance required prior to employment

Core Competencies

Demonstrates expertise in regulatory submissions and compliance for veterinary medicinal products, with a strong focus on CMC dossier writing and collaboration across multidisciplinary teams. Proficient in managing marketing authorizations and ensuring quality standards in the EU region.

Highest-signal resume keywords

• Regulatory Submissions
• CMC Dossier Writing
• Veterinary Medicines Compliance
• Fluency in English and French
• Collaboration with Multidisciplinary Teams

Hard Skills

• Regulatory Compliance
• Quality Dossier Writing
• Change Request Management
• Veterinary Medicine Regulations
• Laboratory Techniques

Soft Skills

• Team Player
• Planning Skills
• Accuracy Skills
• Cultural Collaboration

Certifications & Qualifications

• Valid Work Permit for France
• Approved Medical Examination
• Security Clearance

Industry Keywords

• Marketing Authorization
• Regulatory Affairs
• Veterinary Medicinal Products
• EU Regulations
• Manufacturing Line Transfer