Regulatory Affairs Associate

Responsibilities

• Compilation of DMF as per Health Authority & Customer requirement

• eCTD and DMF submission preparedness

• Compilation & sharing AP DMF with customers

• Responding to customer queries & support their requirements

• Drafting Regulatory agency queries

• Co-ordinate with CFTs to receive and review documents for DMF compilation

• Review CCF and perform impact assessment

• RIMS data base management

Experience & Qualifications

• Master's degree in a relevant Life Sciences, Pharmacy, Biotechnology, or related discipline.

• Minimum 4+ years of relevant industry experience in the required functional area.