EU Veterinary Regulatory Affairs Specialist

Orion Pharma; Arques; Sur place; EUR 55 000 - 85 000; Plein temps

Avantages offerts par ce poste

Onboarding programme

Collaborative environment

Growth opportunities

Résumé du poste

Orion Pharma is seeking a Regulatory Affairs Officer - Veterinary Medicines to maintain EU marketing authorisations and support a manufacturing line transfer. You will write CMC sections, respond to authorities, and ensure compliance across product information and quality dossiers.

The role requires a chemistry or life sciences degree, CMC dossier writing experience, and fluency in English and French. Collaboration with R&D, QA, and manufacturing is essential, with France-specific regulatory

Qualifications

• Degree in chemistry, life sciences, or related field.
• Experience with CMC dossier writing is required.
• Fluency in English and French is required.
• First experience in regulatory affairs for human or veterinary medicines would be beneficial.

Responsabilités

• Prepare regulatory submissions, mainly for variations for an upcoming manufacturing line transfer.
• Write and update the quality part of the regulatory dossier, i.e. p2.
• Respond to questions from the regulatory authorities.
• Ensure regulatory compliance of veterinary medicine product information and quality dossier.
• Collaborate effectively with internal teams (Regulatory Affairs, Quality Assurance, R&D).
• Submit and monitor change requests following approval of variations or other regulatory activities.
• Verify artwork and promotional materials for the French market.

Connaissances

CMC dossier writing

Regulatory affairs

English & French fluency

Team collaboration

Formation

Bachelor's degree in chemistry or life sciences

Description du poste

Orion Pharma is seeking a Regulatory Affairs Officer - Veterinary Medicines to maintain EU marketing authorisations and support a manufacturing line transfer. You will write CMC sections, respond to authorities, and ensure compliance across product information and quality dossiers.

The role requires a chemistry or life sciences degree, CMC dossier writing experience, and fluency in English and French. Collaboration with R&D, QA, and manufacturing is essential, with France-specific regulatory