Opportunity in Regulatory Affairs(formulation) as Executive/Manager in Titan Labs – 05 posts
1)Dossier Preparation ACTD/CTD/Country Specific for domestic or international market (CIS , Franko West Africa & South Est Asia 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) Dossier Checking of subordinates in ACTD/CTD/Country Specific format
4) To review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R&D/ADL against DMF/Dossier requirements
5) To Co-ordinate /to visit with respective dept. in HO /Plant /ADL/R&D for documents & samples required for dossier / registration purpose.
6) Co-ordination with API /PM vendors to resolve technical quires w.r.t. regulatory requirements
7) Artwork Checking & development for registration and commercial purpose as per regulatory requirement
8) To Maintain & Update all documentation & dossier record; to update registration status.
We are looking for appropriately qualified candidates with 4 to 6 years of relevant in Regulatory Affairs with a regulated Pharma company should have exposure in ROW Market, Franko west African Countries, Southiest Asian Countries.
Experience: 4-6 Years
Location: Ghatkopar, Mumbai
Education: Bpharma, Mpharma
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: RA
Package: 4 lacs
End Date: 5th December, 2016
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