[Hiring] Regulatory Affairs consultant @Excelya

Role Description

This role is an exciting opportunity to contribute to a dynamic, ambitious team in the Regulatory Affairs department. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

• Reporting to the Registration Department Team Manager, you are responsible for all activities related to the obtention, follow-up and maintenance of Marketing Authorizations (MA) in France and Europe, including:
• Submission and follow-up of Marketing Authorization applications at both national and European levels.
• Preparation, submission and follow-up of regulatory evaluations with Competent Authorities for: pharmaceutical variations, MA renewals, Requests for Amendments to Product Information (DMI), regulatory variations, up to their practical implementation.
• Monitoring product registration in the Generic Groups Directory.
• Acting as an interface with internal departments, external experts, API manufacturers and contract manufacturing organizations (CMOs).

Qualifications

• Qualified Pharmacist or a Master’s degree
• Solid experience in the field of Regulatory Affairs in Veterinary Medicine
• Well-organized and detail-oriented
• Excellent interpersonal and writing skills in both French and English
• Self-motivated and autonomous
• Able to manage priorities effectively
• Strong analytical and synthesis skills

Requirements

• Operational level of English, with good reading comprehension and written communication abilities

Benefits

• Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.