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Export Regulatory Affairs Specia...

Chemipharm
6th of October, Giza

Export Regulatory Affairs Specialist

6th of October, GizaPosted 1 month ago
130Applicants for1 open position
  • 58Viewed
  • 8In Consideration
  • 40Not Selected

Job Details

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Job Description

  • Establish and develop the regulatory process in different export markets, and ensure adequate registration steps and procedures in new as well as established market.
  • Prepare all Export Registration dossiers for different countries and prepares dossiers for Re-registered products.
  • Prepare and follow up the company registration process to invade new and different markets.
  • Follow up all steps of export registration with agents authorized from chemipharm and Ministry Of Health of different countries including Stability Study, Bioequivalence Study, Inserts, Packs, Analysis and pricing.
  • Follow up any change needed in any product such as change in pack, formula or name to facilitate the registration process in different countries.
  • Establish and maintain good relationship with the internal and external stakeholders.
  • Coordinate with the R&D, Q.C, Production, and Marketing team members regarding the different registration issues.
  • Ensure all registration activities are in compliance with chemipharm and National laws & regulations.
  • Ensure confidentiality in respect of registration files contents.
  • Review carefully compiled files to ensure that content, quality; accuracy and format of submission comply with applicable regulations of the different market.
  • Develop and maintain registration track record for the market.
  • Implement and ensure sustainability of each SOP per function.
  • Expert in preparing CTD files

Job Requirements

  • Bachelor Degree in Pharmaceutical Sciences
  • Background knowledge of regulatory applications and procedures.
  • Excellent English, verbal / written communication.
  • Excellent computer skills.
  • Interpersonal & communication skills.
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