Regulatory Affairs Officer

Jobtailor; Arques; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

Jobtailor in France is seeking a Regulatory Affairs specialist focused on veterinary medicinal products to manage EU marketing authorizations and support a manufacturing line transfer.

You will prepare and write CMC dossiers (module 3/part 2), respond to authorities, ensure compliance, and collaborate with RA, QA, R&D, and Manufacturing teams. Fluency in English and French is required, with valid France work permit.

Qualifications

• Degree in chemistry, life sciences, or related field.
• Experience with CMC dossier writing (module 3 or part 2) is required.
• English and French proficiency.
• Valid work permit for France.
• Approved medical examination and security clearance required.

Responsabilités

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

Connaissances

Regulatory Submissions

CMC Dossier Writing

Veterinary Medicines Compliance

English and French Fluency

Multidisciplinary Collaboration

Formation

Degree in Chemistry or Life Sciences

Description du poste

• 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