Profile Details

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Hire Karima B.

Tunisia

USD 50 /hr

Regulatory Affairs Senior Specialist | Freelance Consultant for GCC Markets (SFDA, UAE, Qatar, Kuwait, OMAN, Bahrain)

Profile Summary

I am a Regulatory Affairs Senior Specialist with over 15 years of experience in the pharmaceutical industry, including 12 years in generic drugs and 3 years in international regulatory consulting. I specialize in product registration and regulatory submissions for GCC countries (Saudi Arabia, UAE, Qatar, Kuwait, Oman, Bahrain). I have hands-on expertise in preparing and reviewing CTD/eCTD dossiers, managing interactions with health authorities (SFDA, MOH, DHA, etc.), and ensuring regulatory compliance throughout the product lifecycle. I offer freelance support for: • CTD/eCTD dossier preparation and review • SFDA, MOH UAE, and Gulf market submissions • Gap analysis, variation filing, renewals • Regulatory strategy and lifecycle management With strong communication and project coordination skills, I ensure timely and compliant submissions for pharmaceutical and biotech companies seeking access to the Middle East markets. I am fluent in Arabic, French, and English. Let’s collaborate to bring your product to the GCC market — efficiently and compliantly.

Subject Matter Expertise

• ☆ Pharmaceutical Regulatory Affairs
• ☆ Regulatory Affairs

Services

• Consulting

Consulting Regulatory Consulting

Work Experience

Consultant, Regulatory Affairs

Regulatory affairs Consultancy

January 2022 - Present

Education

Masters (Science)

Faculty of sciences of Tunis

September 1999 - January 2003

Certifications

• GCC regulatory affairs (RA) Certification

  PRA Consultancy

  January 2023 - Present

• e-CTD

  Extedo

  April 2014 - Present