Rohit Lande
Regulatory Affairs Associate || SLP || EU, US, AU, RoW, CH, TH, CA, GCC || eCTD & CTD Publishing
- Role
- Regulatory Affairs Associate at Parexel
- Location
- Thane, MH, IN
- LinkedIn followers
- 500 followers
About Rohit Lande
Experienced Associate with a demonstrated history of working in the information…
Experience
Regulatory Affairs Associate
Aug 2021 — Present · Mumbai, IN
With the use of Insight Publisher, Publishing and submission of EU Submissions via CESP, MHRA & EMA gateway i.e. CP, NP, DCP & MRP.[For submissions like: Variation type I, IA, IB, IAIN, II, PRAC, Renewals, Core packages, CTA and LC-CMC, Nat-Var, Pharma-MAT]Compiling documents and generating output in eCTD, CTD using InSight Publisher and cross-reviewing.Creating Leafs and assigning documents in it as per provided OPR sheets and Veeva vault binders.Reserving eCTD sequences prior to addition of documents and cross-checking it. Validation of compiled output by Lorenz eValidator as well as EURS validator
Education
CRBTech Pune
Postgraduate certificate
2016 — 2016
ICFAI University, Sikkim.
Master's degree
2015 — 2017
Bachelor of Pharmacy (B.Pharm.) From ICPR, Kalyan
Bachelor of Pharmacy (B.Pharm.)
2008 — 2013
Skills
- Pharmacists
- Pharmacy
- Healthcare Management
- Hospitals
- Medicine
- Regulatory Affairs
- Clinical Trials
- Fda
- Drug Safety
- Public Health
- Pharmacovigilance
- Patient Safety
- Ich Guidelines
- Medical Terminology
- Healthcare
- Ich-Gcp
- Drug Development
- Drug Discovery
- Clinical Research
- Clinical Pharmacology
- Clinical Data Management
- Regulatory Requirements
- Healthcare Information Technology
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