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Regulatory Affairs Manager API

Employer
NonStop Consulting
Location
Italy
Salary
Negotiable
Closing date
Aug 10, 2019

View more

Sector
Pharmaceutical, Regulatory Affairs
Contract Type
Employee
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional

Job Details

NonStop Pharma is currently recruiting for a 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

The Regulatory Affairs Manager will report to the QP having the following 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 N Pharma.

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

    Company

    Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries. 

    Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery.  Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.

    The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors. 

    Company info
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