EU Veterinary Regulatory Affairs Officer | CMC Writer Path

Orion Corporation; Arques; Sur place; EUR 48 000 - 72 000; Plein temps

Résumé du poste

Orion Pharma in France is seeking a motivated Regulatory Affairs Officer for Veterinary Medicines to maintain marketing authorizations across regions, with focus on the EU, and potential to specialize as a CMC writer. You'll work with R&D, QA and Manufacturing to ensure compliance, prepare variations, update the quality part of the dossier, respond to authorities, and verify artwork for the French market.

This role offers onboarding and the chance to grow within Animal Health, a global division

Qualifications

• Degree in chemistry, life sciences, or related field.
• 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 planning and accuracy skills.
• Ability to collaborate with people from various countries and cultures.
• You hold a valid work permit for France.

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

Regulatory submissions

CMC writing

Cross-functional collaboration

English & French fluency

Attention to detail

Formation

Degree in chemistry or life sciences

Outils

CMC dossier writing

Description du poste

Orion Pharma in France is seeking a motivated Regulatory Affairs Officer for Veterinary Medicines to maintain marketing authorizations across regions, with focus on the EU, and potential to specialize as a CMC writer. You'll work with R&D, QA and Manufacturing to ensure compliance, prepare variations, update the quality part of the dossier, respond to authorities, and verify artwork for the French market.

This role offers onboarding and the chance to grow within Animal Health, a global division