International Regulatory Affairs Manager - API

Location
Italy
Salary
Negotiable
Posted
Jul 13, 2019
Closes
Aug 12, 2019
Ref
NM.01.5555
Contact
Nick Menichini
Jobseeker Type
Professional
Organization Type
Corporate
Contract Type
Employee
Hours
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.

Responsibilities

  • 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.

    Email Address: n.menichini@nonstop-pharma.it

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