Senior Regulatory Affairs Specialist

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