Regulatory Affairs Specialist | Lugano

  • Location
    Lugano, Ticino
  • Category
    Chemistry, Pharma, Biotech
  • Contract Type
  • Industry
    Pharmaceuticals / Chemicals
  • External Reference

Our client is a swiss pharmaceutical company based in Ticino and is looking for a

Regulatory Affairs Specialist

Tasks and Responsibility

The Regulatory Affairs Specialist will provide regulatory support to ensure regulatory compliance and obtain national and international authorizations and their lifecycle maintenance under the direct control of a supervisor.
  • Support the preparation, submission, and maintenance of world-wide product registrations in their International market
  • Critically and autonomously prepare/revise the regulatory documentation for registration purposes (MAA, variations, renewals, etc.) intercommunicating with internal departments, local partners/MAHs, and external consultants.
  • Constantly remain updated on new regulations issued by HAs and other regulatory organizations.
  • Review product labeling for compliance with global labeling regulations.
  • Ensure the registration documents are prepared and kept updated according to the regulatory requests of each relevant Health Authority.
  • Collaborate with the Quality Assurance and Pharmaceutical Development department to assess the regulatory impact of Change Controls according to the internal SOP.
  • Ensure that the national texts of Company products are regularly updated and uploaded to national databases, where necessary, either directly or through local partners or consultants.

Knowledge and Skills

  • 5-year degree in a scientific discipline (Pharmaceutical Science, Chemistry, Biology)
  • At least 4-5 years' regulatory affairs experience (this is a MUST!)
  • Deep knowledge of pharmaceutical legislation and regulations
  • Experience in EU registration procedures (MRP/DCP MAA, post approval changes, extensions, and renewals).
  • Preferably previous experience with global registrations
  • Preferably CMC (quality part of the dossier) knowledge
  • Very good English communication and writing skills (knowledge of Italian, French or German would be an asset)
  • Organizational skills and regulatory project management skills
  • Ability to resolve conflicts and develop a course of action leading to beneficial outcomes
  • Cultural awareness and sensitivity to achieve results across regional, national, and international borders
  • Commitment to continuous improvement

Vostro contatto

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Il numero di referenza e 050-MACA-112039-141-IT.