Job for Senior Manager in Regulatory Affairs at Titan Labs
Titan Laboratories Pvt. Ltd. is the one of select few Company in india with dedicated state of art WHO GMP facility for producing high quality Sustained and Modified Release Pellets, DC Granules& Taste Masked Granules. The plant is located in green belt of mahad industrial zone about 180Kms from mumbai. It is strategically located on well connected Mumbai-Goa Highway.
Post: Sr. Manager - RA (02 post)
1) Handling team of 10 to 12 People
2) 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.
3) To evaluate & respond to any regulatory query, customer requirements that may arise from health authority so as to satisfy the query.
4) Dossier Checking of subordinates in ACTD/CTD/Country Specific format
5) To review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R&D/ADL against DMF/Dossier requirements
6) To Co-ordinate /to visit with respective dept. in HO /Plant /ADL/R&D for documents & samples required for dossier / registration purpose.
7) Co-ordination with API /PM vendors to resolve technical quires w.r.t. regulatory requirements
8) Artwork Checking & development for registration and commercial purpose as per regulatory requirement
9) To Maintain & Update all documentation & dossier record; to update registration status..
We are looking for appropriately qualified candidates with 5 to 10 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: 5-10 Years
Education: Bpharma, Mpharma
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: RA
Package: 7.50 lacs
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Titan Laboratories Pvt. Ltd
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