EU Veterinary Regulatory Affairs Specialist

Orion Corporation; France; À distance; EUR 55 000 - 75 000; Plein temps

Avantages offerts par ce poste

Onboarding programme

Collaborative environment with diverse

Competitive salary, benefits

Résumé du poste

Orion Pharma in France seeks a motivated Regulatory Affairs Officer - Veterinary Medicines to maintain marketing authorizations across regions, with a focus on EU. You will collaborate with R&D, Quality Assurance and Manufacturing to ensure compliance for veterinary products and pursue opportunities to specialize in CMC writing.

Your responsibilities include preparing regulatory submissions for variations related to a manufacturing line transfer, updating the quality portion of the dossier, and

Qualifications

• Degree in chemistry, life sciences or related field.
• Experience with CMC dossier writing is required.
• First experience in regulatory affairs for human or veterinary medicines is a plus.
• Fluency in English and French.
• Strong teamwork, planning and accuracy skills.
• Ability to collaborate with colleagues from different countries and cultures.
• Valid work permit for France.

Responsabilités

• Prepare regulatory submissions, mainly variations for a manufacturing line transfer.
• Write and update the quality part of the regulatory dossier (P2).
• Respond to questions from regulatory authorities.
• Ensure regulatory compliance of veterinary medicinal products and information.
• Collaborate with cross-functional teams (R&D, QA, Manufacturing).
• Submit and monitor change requests after approvals.

Connaissances

Fluency in English

Fluency in French

Team player

Collaboration across cultures

Planning and accuracy

Work permit for France

Formation

Degree in chemistry, life sciences

Description du poste

Orion Pharma in France seeks a motivated Regulatory Affairs Officer - Veterinary Medicines to maintain marketing authorizations across regions, with a focus on EU. You will collaborate with R&D, Quality Assurance and Manufacturing to ensure compliance for veterinary products and pursue opportunities to specialize in CMC writing.

Your responsibilities include preparing regulatory submissions for variations related to a manufacturing line transfer, updating the quality portion of the dossier, and