ER
Open to opportunities

Ella Gernun Rozov

@ellagernunrozov

Experienced Regulatory Affairs Manager with over 20 years in pharmaceuticals.

Israel
Message

What I'm looking for

I am looking for a role that allows me to leverage my extensive regulatory experience while contributing to innovative pharmaceutical solutions in a collaborative environment.

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

TL
Current

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.

GI

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

TU

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.

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Ella Gernun Rozov - Regulatory Affairs Senior Manager - TEVA Pharmaceutical Industries Ltd. | Himalayas