Biography
Education
1990-1994: B.Sc. in Biology from Moscow State University, Biological Faculty
1994-1995 M.Sc. in Micro Biology from Moscow state University, Biological Faculty
1999: Ph.D. in Bio Chemistry/ Molecular Biology Institute of Genetics, Moscow, California Technological Institute, USA
- Professional skills:
03.2005 – present «Regulatory/PV expert»
Giving full support for below mentioned activities:
New drug registrations
Registration renewals
Registration of additional indications, dosages, etc.
Changes to existing registration certificates
Follow-up of already submitted dossiers
Clinical trials oversight
“Special situations” regulatory support
Stand-alone regulatory services (dossier compilation, etc.)
PV expert – Responsible for overseeing and leading the process for safety signal management activities, aggregate reports, responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV medical activities.
Experience:
03.2002- «Organon», Holland (Representative Office in Russia, Moscow)
02.2005
Head of Regulatory, Russia / CIS
Responsibilities:
- Registration, renewal, variations in Regulatory documents of medicines (OTC, Rx, MIBP) in Russia and CIS.
- Preparing and submission of Dossier and other documents and materials for regulatory activity in line with requirements of local RA, control of documentation flow and all steps of expertise in Russian Regulatory
- Organizations, receiving RC and other official documents to provide a civil turnover of medicines.
- Tracking of new issued documents related to registration and civil circulation of medicines on regular basis.
- Close co-operation and communication with other departments in the company; conclusion of legal agreements, co-operation with translation and consult agencies,
- Co-operation with Head Office: request/providing of required information, order the samples and RSs for QC.
- Co-operation with packaging department of manufacturer concerning labeling update: creation of new packaging (Russia, CIS), update of current mock-ups and PILs.
09-1998- Branch of Institute of Bioorganic Chemistry, Russian Academy of Sciences,
02-2002 Pushchino, Moscow region
Engineer, senior Researcher
Medical-Biological Department, Pharmacology division
Professional Training and education
2010
Pharmacovigilance Training, USA
2006-2007
Executive Business Management. G.V. Plekhanov Russian Economic Academy, Moscow.
Professional skills
- Huge experience in regulatory work including Research and Development
- Experience of working for largest Western pharmaceutical and biotechnological companies;
- Detailed knowledge of all registration procedures and requirements and the latest global developments in Pharma ceutical industry.
- Reputation for excellence among participants
- Full understanding in formulation, quality control and safety efficacy of Pharmaceutical products
Presently giving full regulatory support to 22 companies in terms of registration of Finished product formulations and registration of APIs
Over 27 years experience
Personal features
Persistent, creative, result- oriented, hard-working, accurate, reliable, team- player, optimistic.
Fluent in Russian, Spanish, English, Hindi, Bengali
Communicate in Italian and Portuguese (writing and reading)
