Profile Details

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USD 75 /hr

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Hire Dr. Nazanin S.

Iran

USD 75 /hr

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

Profile Summary

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.

Subject Matter Expertise

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

Services

• Consulting

Consulting Business Strategy Consulting, Healthcare Consulting, Regulatory Consulting

Work Experience

Regulatory affairs manager

Merck (Germany)

- Present

regulatory affairs manager

Merck KGaA

June 2016 - December 2024

Education

PhD (Chemistry)

Roskilde University - Denmark

January 2012 - January 2014

Masters of Science

Islamic Azad University, North Tehran - Iran

January 2005 - January 2008

Certifications

• Development of Regulatory Strategy for Oncology Products in MEAR Region

  Merck

  January 2022 - January 2023