52 days ago on vifor.avature.net


Vifor Pharma AG

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Ihr Profil
We are currently looking for an experienced Regulatory Affairs Manager to join our RA team. You will provide support for the maintenance and compliance of a major existing marketing authorization in the US and Europe, successful submissions of variations, extension applications and line extensions according to the company strategy.

Based in our Headquarters in Glattbrugg/Zurich, you will report to the Regulatory Affairs Lead for the Renal Therapeutic group and your responsibilities will include:
  • Responsible of designated regulatory projects and compliance with respective deadlines
  • Submission of variations and maintaining existing marketing authorization mainly in the US and EU
  • Interaction with Regulatory Affairs Authorities, 3rd parties, US agents and distribution partners
  • Interfacing with other departments on a national and international level
  • Participation and contribution in meetings, such as Technical Team, Supply Chain, Life-Cycle-Management etc.
  • Compiling and updating regulatory dossiers according to international guidelines (EU, FDA, ICH)
  • Specialized tasks within the framework of Regulatory Affairs activities, e.g. support development projects with respect to regulatory requirements and responsibility for designated regulatory projects
  • Administration of regulatory documentation and ensuring the traceability of regulatory history (filing, archiving, database etc.)
  • Joint responsibility for meeting Regulatory Compliance
  • Keeping up to date with the latest regulatory requirements

The successful candidate will bring a University degree in life science (ideally in pharmaceutical sciences), or a medical degree and fulfill the following criteria:

  • Minimum 5-7 years of relevant experience in Regulatory Affairs
  • Good interpersonal, communication, negotiation and problem-solving skills
  • Strong analytical skills
  • Ability to work under pressure
  • Experience to work cross-functionally, experience to liaise with different stakeholders
  • Good knowledge of Microsoft Office and Internet databases
  • Fluency in English both in writing and speaking
  • Self-assertion, capacity for teamwork
  • Creative, solution-oriented work approach
  • Strategic thinking and acting

You describe yourself as a self-starter who is highly organized and enjoys working in a team. You set priorities according to needs and resolve work related issues adequately. Your excellent project management skills will ensure your success in this role.

Über uns

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.

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