Regulatory Affairs Manager

3 days ago

Qesm El Moqatam Cairo, Egypt El Arabi Pharma Group ( EPG ) Full time

Job Opportunity: Regulatory Affairs Manager (Export Focus)

Al Arabi Pharma Group – El Mokattam

Al Arabi Pharma Group
, a leading pharmaceutical company specializing in international exports, is seeking a highly professional
Regulatory Affairs Manager
to join our team at our headquarters in El Mokattam.

Key Responsibilities:

  • EDA Compliance:
    Lead all registration processes with the
    Egyptian Drug Authority (EDA)
    and manage all relevant electronic platforms.
  • Export Dossiers:
    Prepare and manage
    CTD/eCTD dossiers
    in compliance with international market requirements and foreign Ministries of Health.
  • Certifications:
    Oversee the issuance of Export Certificates (
    CPP, FSC
    ) and all necessary legalizations for global distribution.
  • Market Expansion:
    Stay updated on international regulatory changes to facilitate entry into new global markets.

Candidate Profile:

  • Education:
    Bachelor's Degree in
    Pharmacy
    (Essential).
  • Experience:
    5 to 8 years
    of experience in Regulatory Affairs, with a strong background in
    Export procedures
    .
  • Technical Skills:
    Deep knowledge of
    EDA electronic platforms
    , CTD formatting, and international WHO guidelines.
  • Languages:
    Excellent command of both written and spoken English.
  • Leadership:
    Proven ability to manage teams and meet strict regulatory deadlines.

Work Details:

  • Location:
    El Mokattam, Cairo.
  • Schedule:
    Sunday to Thursday (Friday & Saturday off).
  • Environment:
    A professional, dynamic environment with competitive compensation.

How to Apply:

Interested candidates are invited to send their updated CV to:

Subject:
Regulatory Affairs Manager

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