Preetham Ganesh Bedrala
Angestellt, Deputy Manager - Regulatory Affairs & RIMS, Freyr Solutions
Bangalore, Indien
Werdegang
Berufserfahrung von Preetham Ganesh Bedrala
Bis heute 3 Jahre und 6 Monate, seit Jan. 2021
Deputy Manager - Regulatory Affairs & RIMS
Freyr Solutions
- Assist Presales - Provide Standard Configuration content for RIMS. - Assist RFPs /RFIs /RFQs of RIMS - Participate in Bid Defense - Developing customer facing materials like Business processes , Best Practices, Process Flows, RACI, Work Instructions etc.
1 Jahr und 1 Monat, Dez. 2019 - Dez. 2020
Consultant - Regulatory Affairs (CORE)
PAREXEL International
- Regulatory Support for the assigned client - Coordination oversight for key client’s projects - File transfer, storage, tracking and archival. - Best Practices, Tip Sheets etc. - Project KPIs, CAPAs , QC of HA deliverables. - Team performance assessment
1 Jahr und 3 Monate, Sep. 2018 - Nov. 2019
SME - Regulatory
Arisglobal
- SME for Regulatory application. - Business processes , Standard configuration content, Best Practices , Process Flows, RACI, Work Instructions. - Live Demonstrations - Regulatory Industry standard practices forum - Presales, RFP/RFI/RFQ - Bid Defense - Sandbox Evaluations
4 Jahre und 5 Monate, Mai 2014 - Sep. 2018
Consultant - Regulatory Affairs
PAREXEL International
- Project Management - Leading a team of GRAs - Prepare and QC regulatory submissions - Regulatory technical expertise - Regulatory Intelligence collation - Document Management - RIMS - Interactions with HAs.
3 Jahre und 1 Monat, Mai 2011 - Mai 2014
Executive - Regulatory Affairs
Microlabs Ltd.
- Drug Product Registration Execution in RoW - Product Lifecycle maintenance (Renewal, Variations, AgSR, Commitments etc) - Query Responses to HA - Database maintenance
Ausbildung von Preetham Ganesh Bedrala
1 Jahr und 11 Monate, Juni 2009 - Apr. 2011
Pharmacy
Rajiv Gandhi University of Health Sciences
Pharmaceutics
10 Jahre und 1 Monat, Juni 2004 - Juni 2014
Pharmacy
Rajiv Gandhi University of Health Sciences
Ph'ceutics Org. Chem Inorg. Chem Microbiology & Biotech Pathophysiology Biochem Medicinal Chem Jurisprudence Pharmacognosy & Phytochemistry Pharmaceutical Engineering Pharmacology & Toxicology Tech & biopharmaceutics Instrumental Analysis Pharmacokinetics Clinical & Hospital Pharmacy
Sprachen
Englisch
Muttersprache