Regulatory Affairs Officer

Teoxane SA

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  • Date de publication :

    23 février 2024
  • Taux d'activité :

    100%
  • Type de contrat :

    Durée indéterminée
  • Lieu de travail :

    Genève

Vous retrouverez l'intégralité de nos offres d'emploi en cliquant ici : https://www.teoxane.com/.

Regulatory Affairs Officer

Teoxane Laboratories were established in Geneva, Switzerland, in 2003. They are specialized in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics. Teoxane strength is to offer a global patient care. Using its products, practitioners are able to fill all kinds of wrinkles, from the finest to the deepest, to restore youthful volume to the face, and to treat the neck and décolleté, with natural results. The strength of Teoxane is also its human size and independence. Teoxane has a total freedom of thoughts, action and innovation which makes the company unique.

In the frame of the growth of our business, we are looking for a :

Senior Regulatory Affairs Officer (Asia)

Main responsibilities

  • Under the supervision of the Regulatory Affairs Manager in charge of Rest of the World countries :
    • Identify, analyse and share the regulatory requirements for the concerned Asian countries (including China and Japan)
    • Prepare and write registration dossiers for Asian countries
    • Lead the cross-functional team for geo-expansion project
    • Manage the follow-up of the registration procedures and prepare responses to locale competent authorities requests
    • Manage the maintenance of licenses in the concerned countries
    • Validation of promotional materials
  • Prepare and support inspections conducted by Competent Authorities
  • Key contact and support for distributors and local Regulatory partners of the concerned countries
  • Be responsible for monitoring, interpreting and implementing new regulatory requirements for the concerned countries in collaboration with the distributor and Regulatory local partner (regulatory watch)

Your profile

  • Minimum 5 years experiences in a regulatory affairs position for Asian countries, preferably in medical devices
  • Team player and enthusiastic individual, versatile and dynamic, strategic minded, analytical and detail oriented, rigorous
  • Ability to work in a dynamic environment
  • Ability to work in and to lead cross-functional team
  • Be familiar with Asian culture
  • Be familiar with China & Japanese regulations would be an asset
  • Fluent in English with at least a B2 level in French

Contact

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