Elmira Karamfilova Vural, MTOPRA

Elmira Karamfilova Vural, MTOPRA

Associate Director Regulatory Affairs @ Alnylam Pharmaceuticals

About

Elmira Vural is a highly experienced Regulatory Affairs professional with extensive experience in the pharmaceutical and clinical research industry, primarily focused on EU, UK, Swiss, Australian, and Middle Eastern markets. Currently serving as Associate Director of Regulatory Affairs at Alnylam UK. Her expertise includes leading global regulatory strategies, handling filings and post-approval activities across multiple regions, providing strategic advice, mitigating regulatory risks, coordinating submissions and responses to regulatory authorities, and serving as a critical liaison between internal teams and external partners, with previous roles at Fortera and IQVIA. Elmira holds a Bachelor of Science in Biology and a Master of Science in Drug Regulatory Affairs. She combines academic knowledge with practical experience and is a valuable asset in navigating complex regulatory landscapes in the pharmaceutical sector. Underpinning their practical experience with strong academic credentials.

Country

-

City

United Kingdom

Industry

Biotechnology

Skill

Public Affairs, Strategic Thinking, Molecular Genetics, Project Management, Regulatory Strategy Development, Clinical Operations, Drug Development, Good Clinical Practice (GCP), Written Communication, Scientific Background, Regulatory Strategy, EMA, Communication, Clinical Monitoring, Clinical Development, Oncology, Regulatory Submissions, Clinical Data Management, Pharmacovigilance, Pharmaceutical Industry

Experience

Alnylam Pharmaceuticals

Associate Director Regulatory Affairs

Alnylam Pharmaceuticals

LinkedIn
2025-7 - Present · 1 yr 3 mos

Regulatory Affairs Head for Asia Pacific & Global Regulatory Strategy

Alnylam Pharmaceuticals

Senior Manager, Global Regulatory Strategy

Alnylam Pharmaceuticals

LinkedIn
2023-7 - 2025-7 · 2 yrs 1 mo
Alnylam Pharmaceuticals

EU CTR Implementation Lead

Alnylam Pharmaceuticals

LinkedIn
2022-4 - 2024-9 · 2 yrs 6 mos
Alnylam Pharmaceuticals

Regulatory Affairs Manager

Alnylam Pharmaceuticals

LinkedIn
2021-1 - 2023-7 · 2 yrs 7 mos
Alnylam Pharmaceuticals

Principal Regulatory Specialist

Alnylam Pharmaceuticals

LinkedIn
2020-7 - 2021-1 · 7 mos

Maidenhead, England, United Kingdom

Alnylam Pharmaceuticals

Senior Regulatory Operations Specialist

Alnylam Pharmaceuticals

LinkedIn
2018-10 - 2020-7 · 1 yr 10 mos

Maidenhead, Berkshire, United Kingdom

LabCorp Clinical Trials

Global Regulatory Submissions Specialist

LabCorp Clinical Trials

LinkedIn
2017-6 - 2018-9 · 1 yr 4 mos

Maidenhead, Berkshire, United Kingdom

LabCorp Clinical Trials

Global Site Services Specialist

LabCorp Clinical Trials

LinkedIn
2015-1 - 2017-5 · 2 yrs 5 mos
IQVIA

Regulatory Specialist 1

IQVIA

LinkedIn
2014-6 - 2015-1 · 8 mos
IQVIA

Senior Clinical Trial Administrator

IQVIA

LinkedIn
2011-5 - 2014-5 · 3 yrs 1 mo
Altis CRO

Clinical Research Associate

Altis CRO

2010-8 - 2011-4 · 9 mos
Bayer

Clinical Trial Associate

Bayer

LinkedIn
2010-7 - 2010-8 · 2 mos

Istanbul, Turkey

Bayer

Laboratory Assistant

Bayer

LinkedIn
2009-8 - 2009-11 · 4 mos

Monheim am Rhein, North Rhine-Westphalia, Germany

Collaborated in a project with an environmental team. Training on a project with molecular biology and microbiology technics & assisting to Dr. Andreas Mehl activities in the areas of resistance research, monitoring or strategies

Gelisim Tip lab.

Laboratory Assistant

Gelisim Tip lab.

2008-10 - 2009-5 · 8 mos
Bulgarian Ministry of Environment & Water

Internship on National Sustainable Development Strategies in EU

Bulgarian Ministry of Environment & Water

2007-7 - 2007-9 · 3 mos

Training on National Sustainable Development Strategies in the European Union .

Istanbul University Aziz Sancar Institute of Experimental Medicine

Genetics Laboratory Research Assistant

Istanbul University Aziz Sancar Institute of Experimental Medicine

2005-4 - 2006-5 · 1 yr 2 mos

Istanbul, Turkey

Assisting to Dr. Burcak Vural in a project on Small Cell Lung Cancer. · Training molecular biology and genetics technics.

Education

University of Nicosia

University of Nicosia

LinkedIn

Drug Regulatory Affairs

2021-8 - 2022-12 · 1 yr 5 mos
Boğaziçi University

Boğaziçi University

LinkedIn

Medical Systems and Informatics

2013 - Present · 13 yrs
Istanbul University

Istanbul University

LinkedIn

Science Faculty, Biology

2008 - Present · 18 yrs

Elmira Karamfilova Vural, MTOPRA's Contact Information

Email

******@***.com

Phone

(**) *** ****

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