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] - Valuable in data management

Contact Person: HR
Contact no. -+91-XXXXXXXXXX

Location :- Noida

Pay: ₹18,000.00 - ₹45,000.00 per month

Work Location: In person

📌 Executive Regulatory Affairs (India)
🏢 Florencia Healthcare (P
📍 India