Anton Berezhko
Global Regulatory Strategist @Sanofi
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WORK HISTORY
Global Regulatory Strategist @Sanofi
EMA CP MAAEMA PIPsEMA PRIME Submission readiness meeting
EDUCATION
Université Paris-Saclay
Doctor of Pharmacy (Pharm.D.), Pharmacie
Université Paris-Saclay
Master's degree
SKILLS
ABOUT ANTON BEREZHKO
Resilient and solution-focused* Drives collaboration across functions* Adaptive in fast-paced environments* Strong cross-functional communicatorSum up of skills - Lead of EMA Centralized Procedure MAA- Presubmission activities including EMA PIP, Scientific Advice, PRIME Submission readiness meeting. FDA Pre-IND, FDA IND- Experience at Global, Region and affiliate levels- Strong knowledge of Emerging Markets regulation- Effective organization and optimization of operational processes in a multicultural environment- Project management: regulatory insight, anticipate difficulties, find time winning solutions and opportunities- Biologic medicinal product dossier preparation for new registrations and product license management Bilingual French/Russian, English (Full professional proficiency), Ukrainian
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