Regulatory Affairs Specialist

il y a 4 jours


Paris, Île-de-France Zentiva Group, a.s. Temps plein

About Our Company:

Zentiva Group, a.s. is a leading generic pharmaceutical company with a strong presence in Europe. With a team of over 4,700 dedicated employees, we strive to become the leader in generic medicines and over-the-counter products in Europe, providing high-quality healthcare solutions to our patients.

We believe that access to healthcare should be a right, not a privilege. Today, more than ever, people need access to affordable, high-quality medicines. At Zentiva, we work in partnership with doctors, pharmacists, wholesalers, regulators, and governments to provide the daily solutions we all depend on.

About Your Missions:

In the Regulatory Affairs Department, you will support the Regulatory Affairs team in managing the daily activities of the service, including:

  • New marketing authorization applications
  • Life cycle management (modification requests, preparation of annexes for registered medicines in European procedures, renewals of marketing authorizations, responses to questions, etc.)
  • Updating regulatory databases
  • Review and validation of packaging articles
  • Review and validation of promotional and non-promotional documents
  • Regulatory monitoring
  • Interface with the parent company
  • Interface with health authorities
  • Transversal projects in collaboration with other departments of the subsidiary (Quality, PV, marketing, supply chain, legal, etc.)

About Your Profile:

This is an internship position (Contrat de professionnalisation or d'apprentissage) for 12 months, within a Master 2 program in Regulatory Affairs. You have preferably already completed an internship in Regulatory Affairs in the pharmaceutical industry or a public institution.

You are serious, versatile, autonomous, and open-minded, and you are recognized for your personal qualities. Join the Zentiva team and contribute to our mission to provide high-quality healthcare solutions to our patients.

Zentiva Benefits:

  • Headquarters located 5 minutes from the RER B Gentilly
  • Telecommuting possible 2 days a week
  • Transportation reimbursement up to 80%
  • Integration into the Zentiva France community of interns and alternates


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