Regulatory Affairs Manager EAEU/APAC - Geneva

Ort: Switzerland - Meyrin/Geneva

Funktion: Regulatory Affairs

Firma: OM Pharma

Marilda Martins

International Talent Acquisition Specialist

+41 58 851 67 69

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Ihr Profil

We are currently looking for an experienced Regulatory Affairs Manager with focus on the EurAsian Economic Union and APAC markets to join our team. You are responsible for the creation and implementation of regulatory strategies based on the good knowledge and appropriate interpretation of guidelines and directives. Based in Geneva, you report to the Regulatory Affairs TA and International Team Lead and your responsibilities include:
  • Keep up to date with the latest regulatory requirements with the focus on the regulatory strategy in EurAsian Economic Union and APAC.
  • Act as Point of Contact between Regulatory Affairs of the partner company, local regulatory representatives of OM Pharma and corporate or regional stakeholders
  • Maintain the assigned Regulatory Databases according to internal guidelines
  • Manage the response to Health Authority questions / requests for information
  • Plan all regulatory activities with the assigned partner companies and ensure timely execution
  • Ensure compliance of regulatory dossiers with legal requirements in close collaboration with other functions of Regulatory Affairs such as the Therapeutic Groups, Labelling, Reg Ops and CMC
  • Responsible for ensuring successful dispatch and submission of new marketing authorizations, life cycle management (variation filings, extension applications etc.) in the assigned territory
  • Drive the approval process.
  • Support GMP inspections of manufacturing sites by competent authorities (i.e. EAEU, Russia, Belarus, Kazakhstan and China inspections)
  • Manage product label information development in accordance with the regional requirements
  • Cooperate with internal stakeholders such as Global Drug Safety, Quality and other departments to ensure compliance and alignment with agreed partner support levels

The successful candidate fulfills the following criteria:

  • Degree in Life Sciences, Pharmaceutical Sciences or Medical
  • 4 to 6 years of experience in Regulatory Affairs in the EurAsian Economic Union and APAC markets
  • Good command of French, English and fluency in Russian both in written and oral conversation
  • Ability to analyze the regulatory requirements (particularly EAEU/APAC regulatory, quality and safety guidelines), perform comprehensive gap assessments and build effective regulatory strategies
  • Excellent communication and negotiation skills at all levels
    Experience with managing EAEU/APAC preparation projects, Russian and Chinese GMP inspections and regulatory activities oversight in CIS/Asian markets
You are a mature regulatory professional, open to new projects and challenges, willing and capable to shape your environment, to setup and to improve work processes, and to influence internal and external stakeholders. Your excellent project management skills will ensure your success in this role.
 

Über uns

Die Vifor Pharma Gruppe – die frühere Galenica Gruppe – ist ein globales Spezialitäten-Pharmaunternehmen, das eigene Pharmaprodukte erforscht, entwickelt, herstellt und vertreibt und ein bevorzugter Partner für innovative patientenorientierte Lösungen ist. Das Unternehmen hat sich zum Ziel gesetzt, ein globaler Marktführer in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu sein und weltweit Patienten mit schweren und chronischen Erkrankungen zu einem besseren Leben in Gesundheit zu verhelfen. Die Vifor Pharma Gruppe verfügt über Produktionsstätten in der Schweiz und in Portugal sowie über ein dynamisches Netzwerk von Vertriebsgesellschaften und Partnern zur weltweiten Marktabdeckung. Das Unternehmen treibt die Expansion seiner weltweiten Präsenz laufend voran, bleibt dabei aber in seinem schweizerischen Heimmarkt fest verwurzelt.

Die Vifor Pharma Gruppe besteht aus Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma, ihrem gemeinsamen Unternehmen mit Fresenius Medical Care, Relypsa und OM Pharma.

Für mehr Informationen gehen Sie bitte auf: http://www.viforpharma.com/de/über-vifor-pharma/wer-wir-sind

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