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Innovation
Consulting

Regulatory Affairs Officer (CH) - 885

We are looking for an RAO to contribute to regulatory activities performed on the RA Platform. Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions, interaction with health authorities on behalf of PLG customers

 

About us

Group 13
Required technical skills:

 

  • CH lifecycle maintenance experience
  • Providing support during external and unannounced audits.
  • Responding to internal requests for technical and/or regulatory information.
  • Assisting with license applications as required.
  • Preparation and submission of documentation for post-approval applications including, variations, renewals and MAH Transfers/COAs
  • Preparation and submission of Technical/Site Transfer Applications
  • Assisting with the preparation of CH Marketing Authorisation Applications
  • Monitor and maintain up-to-date knowledge of national and European guidelines/legislation.
  • Ensuring compliance with all regulatory processes, in readiness for both internal and external audits.
  • Ensuring compliance with the regulations of the Swissmedic
  • Use a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data eg Microsoft Office Suite, Veeva (or comparable EDMS), LorenZ, Trackwise etc
  • A proven ability to consistently deliver to tight timelines, without negatively impacting on quality or departmental budget
  • General regulatory administration duties and compliance requirements
  • Management of artwork generation

Additional Skills

  • Experience of promotional/non-promotional activities would be an advantage
  • Knowledge of Access Consortium would be of benefit
  • Good IT skills/knowledge
  • Good organisational skills
  • Good communication skills
  • Pro-active attitude and able to work on own initiative as well as part of a team
  • Ability to prioritise different workloads/multi-task
  • Personal responsibility for ensuring a high standard of work

Regulatory Affairs Officer (CH) - 885

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