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Edelway/Akka Life Sciences is seeking Senior Regulatory Affairs Consultants

Edelway (Akka Life Sciences) 5<y Senior Level  Zürich, Zürich, Schweiz 22 Jun 2017

Job Description

Edelway/Akka Life Sciences is a pan-European professional services consultancy with offices in Germany, Switzerland, Spain, France, Belgium and Italy providing IT/Pharma Engineering resources to global Life Science clients. With over 750 consultants across Europe.

We are actively looking for

Senior Regulatory Affairs Consultants

to join our practice on a permanent basis.

We can offer you roles for our global clients in Zurich or Basel area.

The Role:

  • Gain and maintain access to the market of medicinal products:
    • Coordinate and submit Marketing Authorization, license renewal, Product transfers. Collaborate with the Regulatory Affairs team
    • Communication with the authority (Swissmedic) and the head office
    • Generate and submit Periodic Safety Update Reports (PSURs / PBRERs)
    • Create and revise (safety) labelling material / product information of medicinal products in collaboration with Marketing, Corporate, and the RA team
    • Coordinate, prepare and submit Clinical Trial Applications (including notification of changes) to Ethics Committees
    • Maintain project/variation tracking lists and/or tools, and generate reports of submission activities
    • Maintain oversight and accuracy of registered information of each medicinal product. Keep public database of SPC/PI and internal product lists up-to-date with registered product / labelling information
  • Provide responses to medical/safety/quality requests from various stakeholders; interrelate with respective Business Units and Medical Information
  • Review and approve promotional material, according to national and Corporate requirements as well as to approved product information
  • Establish and revise documents of Regulatory Affairs processes in the Quality Management System, and conduct local training
  • Comply with national regulations and guidelines, legal, regulatory, quality (e.g., ISO, GxP) requirements and company policies; ensure high ethical conduct

Experience:

  • Pharmacist or life science degree
  • 5 years + of experience in Regulatory Affairs and/or Quality Assurance in a regulated industry (pharma or medical devices) or health care
  • Solid experience in submissions to health authorities
  • Knowledge of GxP, ISO and local quality regulatory requirements.
  • Fluency in English and German or French

If this sound like your next challenge, please send me your updated CV in English at stephanie@edelway.com or call me on +41 58 717 7034.

Contact:
Edelway SA

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