EU Veterinary Regulatory Affairs Specialist - CMC/Dossier

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

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.