Job Description

JOB SUMMARY

Sr. Regulatory Affairs Specialist is the one who Prepare & submit the New Registration files (e-CTD) of pharmaceutical & herbal/healthcare products with SFDA (Internal Registration) & external countries (G.C.C. Countries, Jordan. Lebanon, … etc), Sr. Regulatory Affairs Specialist combine knowledge of scientific, legal and business to ensure smooth products registration, which are developed, manufactured or distributed by a range of companies, and meet the requirements needed by authorities.

RESPONSIBILTIES:

• Prepare and submit new registration dossiers (eCTD) in compliance with SFDA and international requirements.
• Manage product lifecycle activities including variations, renewals, and post-approval changes.
• Ensure all activities comply with SFDA, GCC, and other external regulatory frameworks.
• Monitor changes in regulatory requirements and assess impact on company portfolio.

EDUCATION:

• Bachelor’s degree in pharmacy.
• Knowledge of local and international regulatory requirements and international experience is a plus.
• 2–5 years of experience in Regulatory Affairs within the pharmaceutical industry.

Hands-on experience with:

• SFDA submissions
• CTD/eCTD format
• Variations and renewals