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Pharmaceutical Regulatory Affair...

Heliopolis, Cairo

Pharmaceutical Regulatory Affairs Specialist

Heliopolis, Cairo
Posted 1 month ago
90Applicants for2 open positions
  • 0Viewed
  • 0In Consideration
  • 0Not Selected

Job Details

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Job Description

Document Review and Submission:
   - Review all documentation to ensure accuracy and completeness before submission to the Drug Authority.
   - Upload necessary files on the official Drug Authority portal and maintain submission records.
   - Deliver hard copies of submitted documents to the Drug Authority and obtain acknowledgment receipts.

2. Follow-Up and Monitoring:
   - Monitor administrative progress of submissions through department tracking sheets.
   - Regularly communicate with regulatory bodies to resolve any queries or challenges.

3. Cross-Functional Coordination:
   - Collaborate with internal departments such as Quality Assurance, Marketing, and Supply Chain to gather and align required documentation.
   - Coordinate with the Drug Authority across multiple divisions to address issues and expedite approvals.

4. Compliance Management:
   - Ensure all products meet local and international regulatory requirements.
   - Stay updated on changes to regulatory guidelines and implement necessary updates.

5. Relationship Management:
   - Build and maintain professional relationships with officials at the Drug Authority.
   - Attend regulatory workshops and training sessions to enhance knowledge and stay updated.

Job Requirements


- Bachelor’s degree in Pharmacy, Science, or Veterinary Medicine or any related field.
- Minimum of 1 : 3 years of experience in regulatory affairs.
- Proficiency in computer usage, particularly regulatory portals and documentation tools.
- Strong analytical and communication skills.

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