
Drug Regulatory Affairs Executive
1 week ago
1. Drug Regulatory Affairs - Job description
- Prepare CTD, ACTD Dossiers and file regulatory submissions
- Perform assessments of new or revised products
- Manage complaint documentation (including investigation and
- closure)
- Respond to inquiries from regulatory bodies
- Should be technically well versed with requirements for Medicines
- with fare knowledge about Food supplement, medicines
- To Coordinate with relevant department for arranging documents
- To prepare / compile dossier for allocated products / countries
- To coordinate with account department for handling Local FDA fees / transfer of amount for legalization etc
- To coordinate with courier agency for dispatches of dossier /samples
- To make timely entries of submissions / dispatches
Qualifications :-
- A bachelors degree in B. Pharma
- Experienced with 1 year Should apply.
- Excellent communication skills
- Should be aware about Microsoft office [word / Excel/ PPT] - Good inData management
Contact No
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