Executive – Regulatory Affairs

Job Description

Preparation of applications for various forms and licenses to CLAA and SLA, preparation of post approval variations and query responses. 

Preparation of dossiers in CTD/ACTD format and query responses compilation. 

Review of CMC related documents received from various inter functional departments and provide necessary inputs as per regulatory requirements.

Handling of various online portals

Work Experience

2 to 3 years experience in Biotech regulatory department

Education

Competencies