Amit Das
Regulatory Affairs Manager at AstraZeneca
- Role
- Regulatory Affairs Manager i at AstraZeneca
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Amit Das
Regulatory Affairs Professional with 10 years of experience driving Regulatory…
Experience
Regulatory Affairs Manager i
Mar 2021 — Present · Bengaluru, IN
Performing License maintenance activities - US Annual Reports (NDA, BLA, ODD) & License Renewals for CAMCAR, EU, AP, MEA, ROW markets and Site Registrations. Plus, PSUR dispatch & responding to HA queries• Super User for RegIntel (RegInsight R3), leading from renewals perspective in tool development, plus working on post release activities and helping teams adapt across the organization, thereby conducting Drop-in sessions• Regional POC for LA/CAMCAR region & managing stakeholders (RAD, RPM, RAM, GRL, CMC, labeling, clinical, non-clinical, publishing, RIT & other cross-functional teams)• Managing ERV (Veeva), RegInsight R3, SharePoints, etc, regularly to track/update product lifecycleAccomplishments – Recognized & awarded twice for leading the RegIntel tool development for renewal requirements repository, awarded for contributions to environmental protection, and actively trained new team members on regulatory processes
Education
Institute of Management Technology, Ghaziabad
Master of Business Administration - MBA, Business Analytics
Central Academy
High School, Science (Biology)
2004 — 2006
BHUPAL NOBLES INSTITUTE OF PHARMACUTICAL SCIENCES, UDAIPUR
Master's Degree, Pharmacology
2011 — 2014
Swami Keshvanand Institute of Pharmacy
Bachelor's Degree, Pharmacy
2006 — 2010
Sophia Secondary School
School, LKG-Xth
1992 — 2004
Skills
- Assistant Teaching
- Powerpoint
- Microsoft Excel
- In Vivo
- Pharmaceutical Industry
- Sop
- Tissue Culture
- Microsoft Office
- Standard Operating Procedure (Sop)
- Clinical Trials
- Clinical Research
- Molecular Biology
- Labeling
- Centrifugation
- Pipetting
- Animal Models
- Traineeships
- Pharmacology
- Cell Culture
- Regulatory Affairs
- Seminar Presentations
- Microsoft Word
- Research
- Life Sciences
- In Vitro
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