1. Drug Regulatory Affairs - Job description
Ø Prepare CTD, ACTD Dossiers and file regulatory submissions
Ø Perform assessments of new or revised products
Ø Manage complaint documentation (including investigation and
Ø closure)
Ø Respond to inquiries from regulatory bodies
Ø Should be technically well versed with requirements for medicines with fare knowledge about medicines, food supplement,
Ø To Coordinate with relevant department for arranging documents
Ø To prepare / compile dossier for allocated products / countries
Ø To coordinate with account department for handling Local FDA fees / transfer of amount for legalization etc
Ø To coordinate with courier agency for dispatches of dossier /samples
Ø To make timely entries of submissions / dispatches
Qualifications :-
Ø A bachelor’s degree in B. Pharma
Ø Experienced with (1 to 5 yrs) both can apply.
Ø Excellent communication skills
Ø Should be aware about Microsoft office [word / Excel/ PPT] - Good in data management
Contact Person: HR
Contact no. -9968996869
Location :- Noida
Pay: ₹18,000.00 - ₹45,000.00 per month
Work Location: In person
