Vifor Pharma

_Vifor Pharma, ein Unternehmen der Galenica Gruppe, ist eine der weltweit führenden Gesellschaften im Bereich Erforschung, Entwicklung, Herstellung und Vermarktung von pharmazeutischen Produkten zur Behandlung von Eisenmangel. Das Unternehmen bietet zudem mit den spezialisierten Abteilungen in den Bereichen Infektionskrankheiten/OTX und Consumer Healthcare ein diversifiziertes Portfolio an verschreibungspflichtigen Medikamenten und nicht verschreibungspflichtigen (OTC) Produkten an. Vifor Pharma mit Sitz in Zürich, Schweiz, baut seine globale Präsenz laufend aus und verfügt über ein umfassendes Netzwerk aus Tochtergesellschaften und Partnern weltweit. Für weitere Informationen über Vifor Pharma und die Muttergesellschaft Galenica besuchen Sie bitte www.viforpharma.com und www.galenica.com
Stellentyp: Vollzeit

REGULATORY AFFAIRS SPECIALIST - HQ

Location: Switzerland - Glattbrugg/Zurich
Function: Regulatory Affairs
Company: Vifor Pharma
Lucie Kulhanek
Talent Acquisition Consultant
+41 58 851 83 68
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About you
We are currently looking for a Regulatory Affairs Specialist to join our Regulatory Affairs International Team. Based in our Headquarters in Glattbrugg/Zurich, you will report to the Head Regulatory Affairs International. Your responsibilities will include:
  • Liaise with Regulatory Affairs representatives of Vifor Pharma in Asia-Pacific and with Regulatory Affairs staff members from third parties based in Asia-Pacific
  • Act as principal contact for Regulatory Affairs matters of Asian-Pacific countries
  • Plan regulatory activities in Asia-Pacific
  • Clarify requirements for planned regulatory activities
  • Have oversight on all planned and pending regulatory actions of the assigned medicinal product portfolio in Asia-Pacific
  • Manage the response to Health Authority Requests for Information
  • Manage post-approval processes such as artwork change requests and the provision of regulatory information needed for batch release of finished product according to internal procedures
  • Identify regulatory risks and work on their mitigation
  • Build an Regulatory Affairs expert network within Asia-Pacific
  • Represent GRA International at in-house meetings
  • Maintain the assigned Regulatory Data Base Entries according to internal guidelines
  • Improve business performance by shortening time to market and speed of product change implementation
For this role, we are looking for a strategic thinking and acting person who has the capacity for teamwork. Furthermore, you should demonstrate excellent communication and negotiation skills and bring the following competencies:
  • University degree in life science (ideally in pharmaceutical sciences), or a medical degree
  • 3 years experience in Regulatory Affairs of International Markets preferentially Asian-Pacific markets
  • Good command of English – both written and spoken – command of an additional language of the region would be an asset
  • Intercultural competence
  • Negotiation skills
 
About us

Vifor Pharma, a company of the Galenica Group, is a world leader in the discovery, development, manufacturing and marketing of pharmaceutical products for the treatment of iron deficiency. The company also offers a diversified portfolio of prescription medicines as well as over-the-counter (OTC) products. Vifor Pharma, headquartered in Zurich, Switzerland, has an increasingly global presence and a broad network of affiliates and partners around the world. For more information about Vifor Pharma and its parent company Galenica, please visit www.viforpharma.com and www.galenica.com.

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