Senior Regulatory Affairs Lead, Immunology & Biologics

CEVA Logistics; France; Hybride; EUR 140 000 - 190 000; Plein temps

Résumé du poste

Ceva Animal Health is seeking a Senior Expert Regulatory Affairs - Immunological Products to shape global regulatory strategies across a portfolio of biological products. Based in France, you will collaborate with R&D, Quality, Manufacturing and Marketing to align regulatory plans with business objectives.

You will lead submissions, influence cross-functional teams, mentor colleagues, and represent Ceva in interactions with Health Authorities and trade associations, driving compliance and

Qualifications

• Advanced scientific degree in Pharmacy, Veterinary Medicine, Biology, Biotechnology, or equivalent.
• Minimum 15 years in Regulatory Affairs, ideally in vaccines, biological or immunological products.
• Experience in international and matrix environments.
• Ability to influence strategic decisions beyond the regulatory function.

Responsabilités

• Define and drive global regulatory strategies for immunological products.
• Lead regulatory dossiers submissions (MAAs, extensions, complex variations).
• Mentor Regulatory Affairs team members and build capability.
• Act as senior regulatory reference and escalation point across functions.

Connaissances

Regulatory strategy

Regulatory intelligence

Health authority interactions

Leadership influence

Formation

Advanced scientific degree

Description du poste

Ceva Animal Health is seeking a Senior Expert Regulatory Affairs - Immunological Products to shape global regulatory strategies across a portfolio of biological products. Based in France, you will collaborate with R&D, Quality, Manufacturing and Marketing to align regulatory plans with business objectives.

You will lead submissions, influence cross-functional teams, mentor colleagues, and represent Ceva in interactions with Health Authorities and trade associations, driving compliance and