Svetlana Timofeeva

Regulatory Submission Manager @Medpace

Munich, DE

EMAILS

[email protected]

MOBILE NUMBERS

+91 *********19

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WORK HISTORY

Jul 2014 — Present

Regulatory Submission Manager @Medpace

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SKILLS

Ich-GcpClinical OperationsCardiologyVaccinesClinical ResearchDrug DevelopmentClinical PharmacologyRegulatory RequirementsClinical MonitoringTherapeutic AreasSop DevelopmentMedical AffairsRegulatory AffairsOncologyPharmacovigilanceCROMedical WritingPharmaceutical IndustryRegulatory SubmissionsEdcProtocolSopClinical DevelopmentTrial ManagementClinical Data ManagementBiotechnologyGcpClinical TrialsFdaClinical Trial ManagementR&DLine ManagementQuality AssuranceCtmsMedicineProtocol Development

ABOUT SVETLANA TIMOFEEVA

MD, PhD, professional with 13 years of experience in local and global development of drugs and biologics gained through progressive career development. Key skills include regulatory expertise in Russia and CIS countries, optimizing the performance of geographically diverse teams; leading teams from regulatory submissions till final data analysis; building and maintaining highly effective relationships; creative problem solving; and exceptional interpersonal, organizational and communication skills. Main focus area - Clinical Operations, Regulatory support, Country Lead, Staffing and resourcing, Trainings in GCP and monitoring skills for CRO/R&D staff, investigators etc, Administrative set up and leadership support

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