プロフィール詳細

プロジェクトを作成

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Dr. Nazanin S.に依頼

Iran

Regulatory Affairs Consultant | 18+ Years in Pharma | Ex-Merck | EMEA & MENA Expert

プロフィール概要

I am a pharmacist and senior Regulatory Affairs expert with over 18 years of experience in the pharmaceutical industry, including 9 years in a managerial role at Merck Healthcare KGaA (Near East Region). My core expertise includes global regulatory strategy, international product registration, lifecycle management, and compliance with ICH and local regulations across EMEA and MENA regions. Throughout my career, I have led cross-functional teams, managed regulatory submissions for both innovative and generic products, and established successful collaborations with health authorities and global stakeholders. I bring a deep understanding of market access pathways and regulatory intelligence to support efficient and compliant drug development and commercialization. I am currently available for freelance or project-based collaborations related to: • Regulatory strategy and submissions • Dossier preparation and review (CTD) • Market access and regulatory intelligence • GAP analysis and compliance audits • Support for entering Middle East and EMEA markets Let’s work together to navigate the regulatory landscape and accelerate access to high-quality medicines.

専門分野

• ☆ Biochemistry
• ☆ Drug Development
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Clinical Trials
• ☆ Regulatory Affairs
• ☆ Pharmaceutical Management
• ☆ Regulatory Writing
• ☆ CMC Documentation
• ☆ Project Management

サービス

• Consulting

Consulting Business Strategy Consulting, Healthcare Consulting, Regulatory Consulting

職務経験

Regulatory affairs manager

Merck (Germany)

- 現在

regulatory affairs manager

Merck KGaA

6月 2016 - 12月 2024

学歴

PhD (Chemistry)

Roskilde University - Denmark

1月 2012 - 1月 2014

Masters of Science

Islamic Azad University, North Tehran - Iran

1月 2005 - 1月 2008

認定資格

• Development of Regulatory Strategy for Oncology Products in MEAR Region

  Merck

  1月 2022 - 1月 2023