Export Regulatory Affairs Supervisor

Full time posted 9 months ago in Export , in Regulatory
  • Cairo, 36 ElShikh Mohamed ElNady St., Nasr City, 11371 View on Map
  • Post Date : December 4, 2023
  • Apply Before : March 14, 2024
  • 20 Application(s)
  • View(s) 673
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Job Detail

  • Job ID 5912
  • Career Level Experienced Non-Manager
  • Experience (Min Years) 4
  • Experience (Max Years) 6
  • Age not less 18
  • Age not exceed 25
  • Education Level Bachelor\'s Degree
  • Gender All Gender
  • Industry Pharmaceutical
  • Nationality Egyptian

Job Description

Zeta Pharma is a leading and fast-growing pharmaceutical company dedicated to improving the lives of patients through innovative healthcare solutions.

We are looking for Export Regulatory Affairs Supervisor who will plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures. Also provide responses to regulatory agencies regarding product information or issues.

Job Description:

  • Prepare and maintain required documentations needed for the registration of company products.
  • Coordinate with EDA; Egyptian Drug Authority, to ensure compliance with all regulations and laws as necessary, follow-up with submitted documentations and resolve any issued that may arise.
  • Prepare the registration documentations needed to register in different foreign countries in an effectively and timely manner.
  • Keep up-to-date with changes in regulatory legislation and guidelines and ensure company compliance with government rules and regulations.

Requirements:

  • Bachelor’s degree in Pharmacy is a must.
  • 4-6 years of experience in the pharmaceutical sector.
  • Expert in CTD files and e-CTD preparation and reviewing registration dossiers (countries specialized dossier or CTD).
  • Strong knowledge of the regulatory framework of international pharma legislation, relevant guideline, procedures &requirements.
  • Awareness of preparing submissions of license variations and renewals.
  • Proficiency in spoken and written English and prepared little French language.
  • Excellent communication and presentation skills.
  • Excellent Time management skills.
  • Problem solving and strategic planning skills.

Required skills

Communication skills Decision-making skills Negotiation Organizing Skills Persuasion and leadership skills Problem-solving Strategic Planning Time Managment

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