Regulatory Affairs Specialist At SEDICO Pharma

 

Job Description:

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:

BSc 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”