プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Karima B.に依頼

Tunisia

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

プロフィール概要

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.

専門分野

• ☆ Pharmaceutical Regulatory Affairs
• ☆ Regulatory Affairs

サービス

• Consulting

Consulting Regulatory Consulting

職務経験

Consultant, Regulatory Affairs

Regulatory affairs Consultancy

1月 2022 - 現在

学歴

Masters (Science)

Faculty of sciences of Tunis

9月 1999 - 1月 2003

認定資格

• GCC regulatory affairs (RA) Certification

  PRA Consultancy

  1月 2023 - 現在

• e-CTD

  Extedo

  4月 2014 - 現在