OVERVIEW
FOCUS AREAS
CMC – drugs and biologics
Global Regulatory Strategy
Post-approval regulatory affairs
Elena is an experienced Regulatory Affairs advisor with graduate and post-graduate degrees in Life Sciences with over a decade of professional experience in the pharmaceutical industry.
Her expertise spans a broad spectrum of regulatory environments, including the EU, APAC, LATAM, and MENA regions. Elena’s notable strengths lie in product lifecycle management, post-marketing authorisation regulatory CMC writing, global labelling, and response writing. Her substantial exposure to international regulatory requirements and her ability to manage complex regulatory processes make her an invaluable asset in ensuring that pharmaceutical products meet stringent global standards and reach the market efficiently.
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EDUCATION:
BSc (Hons) Medical Biology, Brunel University
MSc Clinical Embryology, Oxford University
Ph.D. Biological Sciences, Brunel UniversityHONORS & AWARDS:
Clarendon Scholar, Oxford University -
PROFESSIONAL EXPERTISE;
CMC technical writing
Labelling
Packaging materials preparation
GAP analysis
Regulatory Strategy
Project Management
Data Management
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