263 days ago on ctcon.ch

Regulatory Affairs Manager

CTC Clinical Trial Consulting AG

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 Please refer to JobSuchmaschine in your application

Regulatory Affairs Manager

Reference Number: 895059-W
Type of placement: Permanent
Location: Switzerland, North East / Central


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


Main Responsibilities:

  • Responsible of designated regulatory projects and compliance with respective deadlines
  • Submission of MAA,  variations and maintaining existing marketing authorization mainly in the US and EU
  • Interaction with Regulatory Affairs and Health Authorities, 3rd parties, distribution partners
  • Cross-functional leadership of the project, 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

Qualifications and Experience:

  • University degree in life science (ideally in pharmaceutical sciences), or a medical degree
  • Minimum 5-7 years of relevant experience in Regulatory Affairs
  • Experience with EU MAA
  • Previous experience in managing a US FDA licensed product is a benefit
  • Good interpersonal, communication, negotiation and problem-solving skills
  • Strong analytical skills
  • Experience to work cross-functionally, experience to liaise with different stakeholders
  • Fluency in English both in writing and speaking
  • Self-assertion, capacity for teamwork
  • Creative, solution-oriented work approach
  • Strategic thinking and acting
  • Relevant working/residency permit or Swiss/EU-Citizenship required