Regulatory Affairs consultant - health animal

Excelya

2d

About The Position

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role is an exciting opportunity to contribute to a dynamic, ambitious team in 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.

Requirements

• Qualified Pharmacist or a Master’s degree
• Solid experience in the field of Regulatory Affairs in Veterinary Medecine.
• You are well-organized and detail-oriented, with excellent interpersonal and writing skills in both French and English.
• Self-motivated and autonomous, you are able to manage priorities effectively and demonstrate strong analytical and synthesis skills.
• operational level of English, with good reading comprehension and written communication abilities.

Responsibilities

• 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).

Benefits

• At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
• We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience .
• Our one-stop provider service model —offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects.
• Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees