International Regulatory Affairs Manager - API

Jul 13, 2019
Aug 12, 2019
Nick Menichini
Jobseeker Type
Organization Type
Contract Type
Full Time

NonStop Pharma is currently recruiting for a International Regulatory Affairs Manager API on behalf of client with leading position in the pharmaceutical/chemical industry. It's an interesting opportunity to gain international visibility and experience high levels of autonomy and visibility.


  • assistance in the operations concerning QA Assurance
  • composition of technical documents for submission to the regulatory authorities
  • drawing up of technical documentation in response to any clarification requested by the Regulatory Authorities
  • responsibility for the review of analytical methods and specifications
  • direct interaction with QA control and or external laboratories
  • collaborate in inspections carried out by health authorities
  • management of the quality agreements
  • organisation and implementation of the change control system
  • collaboration in the receipt of audits by customers/organisations
  • verification of the batch production records and batch warehouse records
  • plant sanitation
  • execution of internal audits
  • training of internal audits
  • training of personnel
  • Desired Skills

  • scientific degree
  • at least 4/5 years in similar roles, ideally in the API production
  • available for transfer to European Country
  • fluent level of English and Italian
  • time management, project management and people skills
  • To apply, or to organise a confidential conversation, reach out and send your updated word CV to Nicolandrea Menichini, Team Leader specialized within Regulatory Affairs and Pharmacovigilance Recruitment at NonStop Pharma.

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