Regulatory Affairs Associate - Clermont-Ferrand, France - Laboratoires Théa

Laboratoires Théa

Entreprise vérifiée

Clermont-Ferrand, France

il y a 4 jours

Posté par:

Sophie Dupont

beBee Recruiter

Description

VIE
REGULATORY AFFAIRS ASSOCIATE - H/F - (
VIE)

On pourrait commencer par vous donner des chiffres, vous présenter nos valeurs ou notre ambition, même vous raconter l'extraordinaire histoire familiale qui a permis à Théa d'être aujourd'hui le premier laboratoire indépendant en Europe spécialisé dans l'ophtalmologie.

On aurait beaucoup à vous raconter, mais gardons ça pour notre rencontre

READY TO MOVE ?

Attached to Laboratoires Théa HQ RA department, joining Annelise's team, and working with local RA team in Dubai (in Théa subsidiary), you will have the mission to contribute to ensure regulatory activities for the pharmaceutical and medical devices in three countries (Saudi Arabia, Kuwait and Emirates) for products registrations and life cycle.

Your main responsibilities are the following:

Work with the Théa Dubai regulatory team on a wide range of regulatory activities in drugs and medical devices registrations and maintenance of business (for medical devices) for 3 countries (Saudi Arabia, Emirates, Kuwait).
Participate to the compilation of preparation files for the submission of new MA and variations for this 3 countries.
Contribute to the development of regulatory intelligence process at local level.
Assist in the relations between Corporate Regulatory Affairs Department and Local Regulatory Affairs Department
Participate in Regulatory and transversal projects

Venez nous challenger

Ideally, you are a pharmacist or come from a scientific background, complemented by studies in regulatory affairs.

With a minimum of one year of experience in the Regulatory Affairs Department within the pharmaceutical and/or medical device industry, you have demonstrated your ability to navigate international regulatory affairs.

Knowledge or experience with regulatory affairs in the Middle East would be a significant asset.

You are familiar with MS office and databases.

Results-oriented and a true team player, you possess strong time management and prioritization abilities, enabling you to work effectively in a multifunctional and multicultural organization.

You also have excellent organizational skills.

You have a fluent or very good level of English.