11. 01. 2018

REGULATORY AFFAIRS MANAGER

RegijaBeogradski region

Vrsta posla:Stručne i rukovodeće pozicije


Opis
For our client, renowned multinational pharmaceutical company with its representative office in Belgrade, Adecco is looking for experienced and responsible candidates.

Required qualifications:
  • University degree in Medicine or Pharmacy
  • At least 3 years in the pharmaceutical industry on a senior regulatory position
  • Fluency in English 
  • PC literacy

Main responsibilities: 
  • For assigned products ensures timely preparation, submission and appropriate follow-up of new Marketing Authorization applications to the local authorities 
  • Maintenance of assigned, authorized products through timely submission of variations, renewal applications, PSURs and supplemental marketing authorizations
  • Under supervision, ensures that marketing authorizations are maintained in compliance with related regulatory areas, through performing that necessary activities, including variations, renewals and PSURs, with a high standard and within the agreed timeframes and communicate approvals to stakeholders through the correct processes
  • For assigned products, ensures timely preparation and maintenance of local Summary of Product Characteristics, Patient Package Inserts, local physicians' circulars, packaging material and other applicable regulatory documents and local standards and relevant Artwork Management procedures. Implement Prescribing Information within the correct timeframes for compliance
  • Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance
  • Prepares artwork, including package leaflets and all other components in a timely and correct manner and according to relevant Artwork Management procedures
  • Follow the relevant legislation

Candidate’s profile:
  • Excellent communication and interpersonal skills
  • Good organizational and planning skills and meticulous attention to detail
  • Flexible enough to successfully handle conflicting time pressures and a large volume of work
  • Must be able to work both alone and as part of a team
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Broj oglasa JN -012018-3135