Regulatory Affairs Manager APAC - Geneva

Lieu: Switzerland - Meyrin/Geneva

Fonction: Regulatory Affairs

Compagnie: OM Pharma

Votre profil

We are looking for a Regulatory Affairs Manager APAC for our biotech production site in Geneva. Reporting to the RA Regional Head/International, you are responsible for assigned regulatory projects related to the APAC region. Your main responsibilities are as follows:
  • Create regulatory strategies based on the good knowledge and appropriate interpretation of guidelines, directives etc.
  • Ensure successful dispatch and submission of new marketing authorizations, life cycle management (variation filings, extension applications etc.) in the APAC region, especially China
  • Act as a point of contact for all regulatory affairs matters concerning the APAC region
  • Plan all regulatory activities with the assigned partner companies and ensure timely execution
  • Communicate with internal stakeholders such as PV, Quality and other departments to ensure compliance and alignment with agreed partner support levels
  • Improve business performance by shortening time to market and speed of product change implementation
  • Work with the legal department on the regulatory review of existing and establishment of new license agreements
  • Ensure the accuracy and completeness of assigned database entries according to internal guidelines
To carry out this mission, we are looking for a person with the following profile:
  • Degree in the fields of Life Sciences (Master, Pharmacist or PhD)
  • At least 5 years of experience in Regulatory Affairs related to APAC countries / China 
  • Ability to analyze the regulatory requirements (particularly APAC regulatory, quality and safety guidelines), perform comprehensive gap assessments and build effective regulatory strategies
  • Fluent (written and spoken) in English and ideally Chinese (would be strongly valued), French is a plus
You describe yourself as an analytical and result-oriented person who enjoys working in a dynamic environment. Your work is characterized by its accuracy, a proactive approach and by the ability to work under stress and to deal with tight deadlines. You also demonstrate strong leadership, entrepreneurship and negotiation skills, and you like to interact with various stakeholders. 

Are you interested in this opportunity? Apply now and join OM Pharma!

A propos de nous

OM Pharma est une entreprise mondiale de biotechnologie basée à Genève. OM Pharma est aujourd’hui un leader dans la prévention des infections respiratoires et urinaires récurrentes et est également ac¬tive dans le traitement des maladies vasculaires. Elle œuvre dans le monde entier grâce à un sol¬ide réseau de partenaires internationaux et continue à investir dans la R&D pour développer des produits immunothérapeutiques dérivés des microbes, destinés à traiter les troubles immunitaires aigus et chroniques résultant d’infections et d’inflammations.
OM Pharma s’efforce d’améliorer la qualité de vie des patients dans le monde entier en leur donnant accès à une meilleure prise en charge des maladies infectieuses et des déséquilibres immunitaires en gérant l’ensemble du cycle de vie du portefeuille, de la R&D à la production.

Pour plus d’information, visitez notre site: ompharma.com.

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