- pare, review, submit and receive regulatory documentation (e.g., CTD and eCTD submissions) and approvals; ensure follow-through on post-approval commitments.
• Coordinate with licensor regulatory teams to ensure alignment on country regulatory activities.
• Ensure compliance of product labeling, packaging, with local regulations and internal policies. Prepare, submit, follow up the importation plans and custom medical release for human and biological pharmaceuticals and medical devices.
• Prepare and submit lot release documentation as required by drug authority and liaise with the National Control Laboratory for additional testing where applicable.
• Follow up and attend the inspections of imported shipments.
• Prepare, submit and follow up documentations for laboratory testing at EDA labs.
Candidate Qualifications (Must Have/ Good to Have)
- Bachelor’s degree in Pharmacy.
- Minimum of 2 years of experience in a similar position especially for imported products.
- Fluency in English, both written and verbal are a must.
- Strong personality, organizational skills and ability to plan and manage own work agenda independently.
- Good understanding of regulations and related guidelines in Egypt for pharmaceutical, biological regulations and medical device knowledge is preferred.
- Familiarity with different regulatory dossiers (CTD, eCTD) is a must.
- Using digital & Microsoft Office tools; ability to collaborate effectively.
- Strong interpersonal communication and organizational skills.
- Ability to establish and maintain effective working relationships with co-workers, managers, and clients.
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To apply, please send your CV to [email protected] mentioning Regulatory Affairs Specialist
in the email subject line.
