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Regulatory Affairs Specialist

Apply Now Email Me Job ID R0012860 Date posted 10/15/2019 Location: Rome, Italy

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Job Description

  • Scientific Degree (preferably Pharmaceutical Chemistry and Technologies Degree)
  • Previous 3-5 year experience in RA Department
  • Fluent English
  • Full knowledge of local and international (EU) rules/regulations
  • Maintaining knowledge on local regulations up-to-date and assessing impact on product registrations and life-cycle management
  • Daily monitoring of AIFA, EMA, CMDh (Heads of Medicines Agencies), Farmindustria, VdANet websites.
  • Undertaking regulatory activities in line with internal stakeholders (at LOC and Global level) to maximise business opportunities for both new product registrations and ongoing life cycle management
  • Managing type IA, IB and II variations, in the specific: preparing documentation as part of the variation package (including payment request of POL from AIFA website, issues power of attorney declarations if any, checking EN/IT translations of the product information, checking the whole documentation for the submission, etc.), managing approval, publication into the O.J.  and Farmastampati system
  • Preparing and checking sections of dossier (in particular module 3 of dossier: CMC documentation)
  • Good knowledge and previous use of specific electronic system for: management of product registration information and submissions, management and storage of electronic documents, management of quality events (change controls), review/approval of AWs 
  • SOPs/WPs updating activity
  • Requesting of CPP certificates
  • Checking/approving of national bollini
  • Managing and updating of narcotic authorisation
  • Managing parallel imports
  • Managing various websites to upload SmPCs/PILs (e.g. CODIFA, FARMARETE – for German PIL in the Region of Bozen)
  • Participating in T-cons and interacting with GRA (Global regulatory Affairs)
  • Updating and interacting with Business Units/Supply Chain/QA on regulatory status activities
  • Managing batch release for medicinal product derived from human blood or plasma

Locations

Rome, Italy

Worker Type

Employee

Worker Sub-Type

Temporary / Limited Term

Time Type

Full time

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