s

Regulatory Affairs Associate II

Watson Pharma Private Limited
Experience : 0 to 3 Years
Location : Mumbai
Posted on 04 Oct 20
Apply now
Job DescriptionLast Date 02 Dec 20
Review of analytical methods validation protocols and reports of Drug substance and Drug product meeting ICH requirements Review of documents Stability guidance documents for Regulatory Dossier submissions Review of Comparative dissolution profiles Assessment IIG elemental Iron content elemental Impurity assessment reports residual solvents assessment reports etc confirming the regulatory requirements for approval of new formulations strategies Specifications review and approvals API Excipients Inprocess Finished Product Stability etc Review and approval of Change control forms Review and comments of API vendor documents e g Techpack DMF COA s and specifcations to make sure they are as per Regulatory requirement for our ANDA submission Review of various study protocols and reports like photostability split study inuse stability multimedia dissolution and alcohol dose dumping as per product requirement To maintain and update regulatory database for the documents from site Vendors etc required for Regulatory submission
  • Regulatory Affairs Associate II
  • Experience : 0 to 3
  • Job Type : Full Time
  • Interview Type : Face to Face Interview


Job Type : Full Time
Interview Type : Face to Face Interview
Company Description
Watson Pharma Private Limited
Apply now
Active Jobs By Role
Accountant (1514) Admin (231) Agriculture and Dairy (24) Bartender (1) Architect (198) Beauticians / Spa (156) Bouncer (2) BPO / Customer care (3304) Caretaker / Nanny (31) Carpenter (36) Cashier (2) Cleaner / Washer (52) Construction / Laborer (67) Content Writer (695) Counsellor (215) Cook / Chef (481) Data Analytics (13) Data Entry / Back Office (1604) Delivery (990) Design / Animation (1251) Digital marketing / SEO (1075) Draughtsman/Draftsman (4) Doctor / Physician (150) Driver (91) Electrician (124) Engineer (2356) Engraver (5) Event Planner (8) Fire Fighter (12) Fitter (134) Gardener(Mali) (1) Ground Staff (111) Hospitality Executives (684) Housekeeping (200) HR (1737) Insurance Consultant (42) IT - Mobile Developer (443) Lab Technician (76) IT Hardware Engineer (252) IT Software-Engineer (4462) Language Translator (2) Legal (23) Librarian (0) Mechanic (524) Management Trainee (411) Media / Journalism (211) MIS Executive (20) Moulder (0) Nurse (173) Nutritionist / Dietician (4) Operations (158) Office Assistant / Helper (248) Operator / Machinist (240) Packager (21) Painter (8) Pharmacist / Medical Rep (243) Photographer / Videographer (45) Physiotherapist (8) Plumber (9) Research/JRF/SRF (230) Receptionist / Front Office (378) Retail / Store Executive (555) Rigger (2) Sales / Marketing (5706) Security / Guards (50) Sports Trainer (1) Tailor/ dress designer (158) Teacher (333) Tool & Die Maker (0) Tourist Guide (0) Trainer (51) Waiter / Steward (23) Ward Boy (4) Warehouse Executive (16) Welder (89) Others (5821)

SAFETY ALERT!
Teamlease does not charge any kind of payment for a job.