Ella Gernun Rozov
@ellagernunrozov
Experienced Regulatory Affairs Manager with over 20 years in pharmaceuticals.
What I'm looking for
I am a results-oriented Regulatory Affairs Manager with over 20 years of experience in the pharmaceutical industry. My career has been marked by a proven record of successfully managing submissions and ensuring compliance with regulatory standards. I thrive in collaborative environments, working closely with cross-functional teams to achieve common goals.
Currently, I serve as a Regulatory Affairs Senior Manager for International Markets at TEVA Pharmaceutical Industries Ltd., where I lead regulatory activities associated with the development, registration, and maintenance of our branded portfolio across various international markets. My strong analytical skills and comprehensive understanding of global regulations enable me to effectively navigate complex regulatory landscapes.
Throughout my career, I have developed in-depth knowledge of EMA and FDA regulatory guidelines, along with strong project management and organizational skills. I am passionate about contributing to regulatory strategy and ensuring that compliance is maintained throughout the product life cycle.
Experience
Work history, roles, and key accomplishments
Regulatory Affairs Senior Manager
TEVA Pharmaceutical Industries Ltd.
Jan 2012 - Present (13 years 6 months)
Led and planned all regulatory activities for Teva's Branded portfolio (biological and small-molecule) in International Markets. Compiled and submitted registration applications (MAAs) to Health Authorities, ensuring compliance throughout the product life cycle.
Regulatory Affairs Associate
GlaxoSmithKline Israel
Jan 2005 - Present (20 years 6 months)
Led pre-approval and post-approval activities including quality variations, renewals, and label changes. Prepared and maintained labeling, SmPC, and medical device files, supporting regulatory submissions for the Israeli market.
Education
Degrees, certifications, and relevant coursework
Tel Aviv University
Bachelor of Science, Life Science
Studied Life Science at Tel Aviv University, gaining foundational knowledge in biological sciences. Completed a comprehensive curriculum that prepared for a career in the pharmaceutical industry.
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
Job categories
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