22 days ago


Vifor Pharma

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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.