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CMC consultant – Sicily

Pharmalink Consulting are the world’s leading independent Regulatory Affairs Consultancy, providing Regulatory assistance to Global Healthcare Organisations.

Job Description
We are looking for CMC Regulatory Affairs Consultants at all levels to work for one of our clients in Sicily, Italy for 6-8 months. With CMC experience, you will work within pre- and post-approval liaising cross functionally with different groups to ensure product conformity with current regulations. You will also ensure that all documentation is up to date and ensure effective communication and management of Regulatory information.

Essential Criteria
CMC, pre & post license submission experience, MA, QA, CTD, SOP’s, excellent communication & organisational skills.
Excellent written and spoken Italian.

Location
Sicily, Italy

Client
Global Pharmaceutical Company

Job Type
Contract - 6-8 months



Interested? Apply Now.


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  10. Relevant Skills
  11. Prescription Drugs*
  13. Biotech*
  15. Devices*
  17. OTC*
  19. Generics*
  21. CMC eg review/preparation of QOS*
  23. Manufacturing compliance*
  25. Audit work eg CMP, GLP, GCP*
  27. Clinical eg review of protocols, IB, CSRs, Module 2 & 5 documents*
  29. Postmarketing maintenance eg variations/sNDA, postmarketing commitments/safety reporting*
  31. Regulatory operations eg CTD/eCTD/dossier preparation*
  33. Original NDA/MAA filings*
  35. Labeling*
  37. Advertising and promotion*
  39. Regulatory strategy eg RA meetings, filing strategy*
 


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