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Job Detail

Regulatory Affairs Specialist Contractor

Publication date: Sep 29, 2021
  • Function: Hospitals / Pharmaceuticals
  • Nb position: 1
  • Types of contracts: Fixed term contract
  • Academic level: > bachelor level +5
  • Experience: 3 to 4 years
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Missions

  • For assigned products, ensures timely preparation, submission and appropriate follow-up of new Marketing Authorization applications to the local authorities.
  • Secures for assigned authorized products timely submission and follow-up of variations, renewal applications, and supplemental marketing authorizations.
  • For assigned products ensures timely, accurate and compliant labeling translations and artwork preparation.
  • Ensures permanent compliance to local regulatory requirements and to comapany’s policies and procedures.
  • Demonstrates clear leadership in shaping the regulatory environment to support Subsidiary’s objectives.
  • Collects relevant public available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
  • For assigned products and tasks, works alongside the BD, locally, regionally and globally, to support business initiatives.
  • Ensures commercial shipments release by sending appropriate documents to distributors in a timely manner.
  • Liaises with different stakeholders (manufacturing sites, distributorsetc.) and ensures release dossier conformity to HAs requirements.
  • Coordinates labeling activities and Collaborates closely with Registration Managers in order to ensure timely submission.
  • Ensures updates to all regulatory databases.
  • Supports local business with promotional materials and events review and submission.
  • Works in cross-functionality with local departments: Supply, Market Access, Business, Medical Finance, etc.
  • Maintains a positive relationship with internal and external regulatory contacts.
  • Ensures permanent compliance to local regulatory requirements and to internal policies and procedures.
  • Ensures administrative support to the Regulatory Department with internal and external stakeholders (Finance Department, vendors ..etc).

Profile

  •  Pharmacy University Degree.
  •  +3 Experience in pharmaceutical industry.
  •  +2 years relevant regulatory affairs experience.
  •  Excellent command of both French and Arabic.
  •  Fluent in English.
  •  Excellent organizational skills.
  •  Strong communication skills and ability to persuade stakeholders. 

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Location: Algeria, Alger

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