Company: Encore Group
Designation: Officer, Regulatory Affairs
Location: Head Office, Fort - CSMT ( Mumbai )
Department: Regulatory Affairs
Education: B. Pharma / M. Pharma
Working: 5 Days Working, Weekly Off – Saturday, Sunday
Job Description:
1. Dossier Preparation ACTD/CTD/ ECTD Country Specific for ROW market & to ensure error free & timely submissions as per marketing dept. timeline.
2. To evaluate & respond to any regulatory query, customer requirements that may arise from health authority so as to satisfy the query.
3. To review technical documents like process validation, AMV, Stability and CDP etc. received from Site QA or R&D/ADL against DMF/Dossier requirements.
4. To Coordinate with respective dept. in HO /Plant /ADL/R&D for documents & samples required for dossier / registration purpose.
5. Artwork Checking & development for registration and commercial purpose as per regulatory requirement.
6. To Maintain & Update all documentation & dossier record; to update registration status.
Mandatory Requirement :
Must have experience of Dossier Preparation ACTD/CTD/ ECTD Country Specific for ROW market.
Experience - 1 Year to 2 Years
No comments:
Post a Comment