Executive / Senior Executive

Job Title: Executive / Senior Executive, Regulatory Affairs API

Location: Dholka

Experience : 3-6 Years

Job Responsibilities

• Preparation and review of CTD/eCTD format drug master file and its submission to various

regulatory authorities.

• Preparation and review of query response of drug substance for various and less regulated

markets and customers.

• Preparation and review of applicant part and closed part for various authorities for

different customers.

• Preparation and review of annual updates and amendment of drug master files US via

ESG, ASMF via CESP, KDMF via MFDS Korea, CADIFA submission and various less

regulatory countries.

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

• Preparation of CEP LOAs & LOAs and declarations of various customers and authority.

• To collect and evaluate scientific data for assessment in search of discrepancies or

compromises in quality to prepare regulatory submission and customers.

• Preparation and submission of SPL to US FDA authority.Role & responsibilities