Regulatory Affairs Executive - Fort ( Mumbai )

Role & responsibilities

1. Dossier Preparation CTD/ACTD/ ECTD and Country Specific format for ROW market & to ensure error free & timely submissions as per provided timelines.
2. To evaluate & respond to any regulatory query, customer requirements that may arise from health authority so as to satisfy the query.

3. To file post approval variations to regulatory agencies for registered products as per variation guidelines.
4. To review technical documents like process validation, AMV, Stability, PDR and CDP etc. received from Site QA or R&D against Dossier requirements.
5. To Coordinate with respective dept. in HO /Plant / R&D for documents & samples required for dossier / registration purpose.
5. Development of New Artworks and Checking for registration and commercial purpose as per regulatory requirement.

Preferred candidate profile .

6. To Maintain & Update regulatory database for all Manufacturing, Quality documentation, Dossier files and RLD samples.

7. Application and checking of admin documents like product permission, COPPS, FSCs.

Location Head Office, Fort - CSMT

Department - Regulatory Affairs

Education - B. Pharma / M. Pharm

Experience – 3 Years + ( Must have working experience of Dossier preparation for ROW Market )

Working – 5 Days Working

Weekly Off – Saturday Sunday

Send resumes - [email removed]