Hiring for Excellent Opportunity in Aurobindo Pharma Hyderabad for Exp. 1 - 5 Years at Aurobindo Pharma Ltd.
Hyderabad, Telangana, India
Nov 16, 2017
Job Description:We are currently on Search for position in Formulation - Regulatory Affairs (Regulated Market) Job Location :- Aurobindo RC I (Bachupally), Hyderabad Please find below job description: 1. Planning and publishing of high quality regulatory authorities. 2. Preparation of documents as per i and Portable Documents Format specifications to support in filing of original ANDA/NDA, Annual Reports CBE, CBE-30 and Prior Approval Supplement, Amendment filing. 3. Ability to manage workload capacity with ever changing deadlines/requirements with ability to assist & support other members of the team where required. 4. Actively participate in development,review and process improvement activities. 5. Well versed with Computers (Ex. MS Office,PDF,ISI writer etc.) with high speed typing skill. 6. Experience in handling software like PharamaReady, Medxview, EZeCTD, Docubridge, eCTD Express and eCTD submission validation tools viz. Lorenz, EURS, Extedos Gecco. 7. Compliance checking linking,Bookmarking,Rendering Multiple Documents to PDF,Creation of external links,tagging of files as per eCTD requirement. 8. Good Knowledge of ICH/FDA eCTD guidelines. 9. Good grasp of existing regulatory agency standards and formats for submission and make sure that that the CMC publishing output meets these requirements If you are looking out for change then share details to email@example.com