Job Description

2025-05-07

Full time

Regulatory Affairs Specialist

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• Prepare and submit registration dossiers for human pharmaceuticals and Dietary supplements.
• Monitor and follow up on the progress of submitted registration files with the Egyptian Drug Authority (EDA) & NFSA until license approval is obtained.
• Prepare and submit Box inquiry and naming list and follow up with EDA until approval is obtained.
• Prepare and submit pricing files for new products, price increases, and Price renewals, ensuring all required documentation is complete and ensure timely follow-up in accordance with regulatory deadlines.
• Submit stability and bioequivalence and Quality studies and ensure timely follow-up according to regulatory Requirements & deadlines.
• Submit analysis files to CADC, ensure timely follow-up and track progress until final approval.
• Prepare and submit post-approval variations for registered products, ensuring timely follow-up in line with regulatory deadlines.
• Handle the submission of re-registration and renewal applications and coordinate the necessary studies to maintain valid product licenses.
• Submit and follow up on new and updated artwork and leaflets to ensure timely approval and compliance with regulatory standards.
• Coordinate the release Requirements of newly launched products & Post approval Changes, ensuring compliance with EDA regulations.
• Coordinate closely with internal departments including R&D, Quality Control, Marketing, Supply Chain, and Quality Assurance to support seamless regulatory activities and compliance.
• Build and maintain strong, strategic relationships with key stakeholders at the EDA to support regulatory success.

Job Requirement

• B.Sc. in Pharmacy or Veterinary Medicine or science.
• 2–3 years of experience in Human Regulatory Affairs (mandatory).
• Excellent English skills (both verbal and written).
• Excellent computer skills.
• Strong Negotiation & interpersonal and communication skills.
• Excellent problem-solving Skills.

Working Conditions Job Location: 6th of October City.

Benefits

• Social Insurance.
• Medical Insurance.
• Profit Share.
• Transportation is provided.

If you meet these qualifications and are interested in joining our team, please submit your resume and cover letter for consideration. to: human.resources@sedicopharma.com and mention in the subject ” Regulatory Affairs Specialist“

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Benefits found in job post

Medical insurance