Regulatory Affairs Manager @ (February 2024 - October 2024)
Regulatory Affairs Analyst @ (November 2022 - January 2024)
RA Center of Expertise (COE) Analyst, Asia @ (September 2019 - October 2022)
Regulatory Affairs Manager @ (August 2018 - September 2019)
Launch and Regulatory Liason Spv. @ (January 2017 - July 2018)
Technical Dossier Supervisor @ (April 2015 - December 2016)
Drug Regulatory Affairs Associate @ (December 2014 - April 2015)
Regional Regulatory Affairs Specialist @ (May 2011 - December 2014)
International Registration officer @ (September 2005 - April 2011)
Rhensi Margareth Education
University of Indonesia
Pharmacist (Pharmacist Proffesion Program)
2004-2005
University of Indonesia
Bachelor of Pharmacy (B.Pharm.) (Pharmacy)
2000-2004
Rhensi Margareth Skills
Project Management
Pharmaceutical Industry
Regulatory Submissions
GMP
Validation
Regulatory Affairs
Quality Assurance
Pharmacovigilance
Regulatory Requirements
Pharmaceutics
Sop
FDA
Pharmaceutical Sales
Clinical Trials
Product Launch
Change Management
Change Requests
Change Control
Dossier Preparation
dossier
Business Launch
Regulatory Compliance
Dossier management
APAC
Common Technical Document (CTD)
Labelling compliance
New Product Roll Out
Launch timeline
Regulatory Documentation
Apac regulatory
Management
CAPA
Rhensi Margareth Summary
Rhensi Margareth, based in Jakarta, Indonesia, is currently a Regulatory Affairs Manager at PT Kalventis Sinergi Farma. Rhensi Margareth brings experience from previous roles at PT Kalbe Farma, Tbk, PT Kalventis Sinergi Farma, Sanofi and Cargill. Rhensi Margareth holds a 2004 - 2005 Pharmacist in Pharmacist Proffesion Program @ University of Indonesia. With a robust skill set that includes Project Management, Pharmaceutical Industry, Regulatory Submissions, GMP, Validation and more. Rhensi Margareth has 2 emails on RocketReach.
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