Samantha Fernandes
Associate Ii, Regulatory Affairs @Alvogen
Morristown, NJ, US
EMAILS
MOBILE NUMBERS
+91 *********19
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WORK HISTORY
Jan 2022 — Present
Associate Ii, Regulatory Affairs @Alvogen
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Morristown, NJ, US
EDUCATION
2005 — 2008
University of Mumbai
Bachelors of Science, Biotechnology
2008 — 2010
Cranfield University
Masters, Clinical Research
2008 — 2009
Institute of Clinical Research, India
Post Graduate Diploma, Health/Health Care Administration/Management
SKILLS
Trial ManagementMedical WritingPharmacologyHealthcareClinical Operations21 Cfr Part 11NeurologyGcpCardiologyQuality AssuranceChange ControlRegulatory RequirementsClinical TrialsData ManagementEndocrinologyDermatologyProtocolPharmaceuticsClinical MonitoringPharmaceutical IndustrySopDrug SafetyClinical Study DesignStandard Operating Procedure (Sop)PharmacovigilanceDiabetesLifesciencesGmpMedical DevicesClinical ResearchClinical PharmacologyValidationIch-GcpGood Clinical Practice (Gcp)Excellent Interpersonal, Communication and Problem Solving Skills. Proven Ability of Interacting with People of Different Professional and Cultural Backgrounds. Experience Working with Regulatory Information Management Systems Which Track Data RegardingLife Sciences
ABOUT SAMANTHA FERNANDES
Associate II - Regulatory Affairs
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