You're now following
Error following user.
This user does not allow users to follow them.
You are already following this user.
Your membership plan only allows 0 follows. Upgrade here.
Successfully unfollowed
Error unfollowing user.
You have successfully recommended
Error recommending user.
Something went wrong. Please refresh the page and try again.
Email successfully verified.
bangalore, india
It's currently 2:02 PM here
Joined October 2, 2015
0 Recommendations
Amit D.
@amdamit
0.6
0.6
100%
100%
bangalore, india
100%
Jobs Completed
100%
On Budget
100%
On Time
N/A
Repeat Hire Rate
Regulatory Affairs Manager - 6+ years of exp.
Contact Amit D. about your job
Log in to discuss any details over chat.
Reviews
Changes saved
Showing 1 - 1 out of 1 reviews
$20.90 USD
Blog
Ghostwriting
Article Writing
Article Rewriting
Content Writing
•
Experience
Associate - Regulatory Affairs
Jun 2018 - Present
compiling and submitting dossiers (preparation of module - 1, 2, 3, ND, cover letter, application form, etc., required for variation, renewals, new marketing authorization, etc.,) to regulatory authorities (EU & RU-CIS• Performing GAP analysis summaries, updating SmPC, PIL and Label with respect to updated CCDS document for concerned markets (EU, RU-CIS; based on QRD template). Working & regular maintenance of eRIMS database (GRACE-Register & Vault RIM), Electronic Document Management System
Executive - International Regulatory Affairs
Aug 2017 - May 2018 (9 months, 1 day)
• Dossier preparation, compilation & review - NPD, pack change, line extension, market extension, renewals, Novel Food products, etc., (MENA, EU & Africa) for Pharma, AHP (Animal Health Products), CPD (Consumer Products)
• Co-ordinating initiation of labels / cartons / package insert text matter as per the requirements of respective regional MOH. Plus reviewing labels & artworks for region specific compatibility
Executive - Regulatory Affairs
Feb 2016 - Aug 2017 (1 year, 6 months)
• Generating comparison tables/present and proposed documents to assess the changes/deviations between the CCDS and local labeling documents as per QRD Guidelines
• Reviewing & preparing various templates like Weekly Trackers, CCDS implementation trackers, HA approval trackers, CCDS Mailbox mail, CLCN, RSI
• Preparing Clinical & Non-clinical overview & checking referencing and crosslinking of the documents as per SOP
Education
MBA
(Less than a year)
M.Pharma
(3 years)
B.Pharm
(4 years)
Qualifications
Regulatory Compliance Specialization
University of Pennsylvania (Coursera)
2020
https://www.coursera.org/account/accomplishments/specialization/6E8FFQUQTHJX
Registered Pharmacist
RPCI
2013
Registered as a pharmacist in Rajasthan Pharmacy Council, INDIA
Publications
scientific validation of antidiabetic activity of ethanol extract of Ficus glomerata
UK Journal of Pharmaceutical and Biosciences
Manohar L. Samyal, Zabeer Ahmed, Sashi Bhushan, Asha Bhagat, Amit Das, Manju Samyal, “scientific validation of antidiabetic activity of ethanol extract of Ficus glomerata barks and roots in streptozotocin induced diabetic rats”, UK Journal of Pharmaceutical and Biosciences Vol. 2(1), 42-46, 2014. Impact Factor SJIP, 2013—5.105
Contact Amit D. about your job
Log in to discuss any details over chat.
Verifications
Top Skills
Browse Similar Freelancers
Browse Similar Showcases
Invite sent successfully!
Thanks! We’ve emailed you a link to claim your free credit.
Something went wrong while sending your email. Please try again.
Copy to clipboard failed, please try again after adjusting your permissions.
Copied to clipboard.
Loading preview
Permission granted for Geolocation.
Your login session has expired and you have been logged out. Please log in again.