Drug Regulatory Affairs Executive

Position : Drug Regulatory Affairs for Active Pharmaceutical Ingredient

Designation : Executive Role

Location: Dholka, (Near to Ahmedabad), Gujarat

Transportation Service available from Ahmedabad

Candidate must have 2–3 years of experience in Drug Regulatory Affairs within the pharmaceutical industry.

Job Responsibilities :

Preparation of CTD/eCTD format drug master file and its submission to various regulatory authorities including USA, Europe, Canada, Australia, China, Japan, Korea, Brazil and ROW market

· Preparation of query response of drug substance for various and less regulated markets and customers.

· Preparation of applicant part and closed part for various authorities for different customers.

· Preparation of annual updates and amendment of drug master files US via ESG, ASMF via CESP, KDMF via MFDS Korea,

· Preparation and submission of CEP applications and responses to EDQM via CESP.

· Preparation of CEP LOA’s & LOA’s and declarations of various customers and authority.

· To collect and evaluate scientific data for assessment and prepare regulatory submission for authorities and customers.