Export Regulatory Affairs Specialist

Eva Pharma - Cairo/Giza, Egypt

95
Applicants for
1 open position
44
Seen
68
Rejected
Experience Needed:
1 to 3 years
Career Level:
Experienced (Non-Manager)
Job Type:
Full Time
Salary:
Negotiable
Languages:
English, French
Vacancies:
1 open position
About the Job
  • Establish and develop the regulatory process of EVA PHARMA 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 EVA Pharma 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 Eva Pharma 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.
Job Requirements
  • Bachelor Degree in Pharmaceutical Sciences
  • 1 - 3 years of experience in similar position.
  • Excellent command of English and French languages.
About this Company

Established in 1997, Eva Pharma is one of Egypt’s leading pharmaceutical companies, built on the heritage of Les Laboratoires Delta, Egypt’s second oldest pharmaceutical company.

Today, Eva Pharma is the fastest growing pharmaceutical company in the MENA region,... (More)

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