Sandoz India Pvt Ltd
Location
Secunderabad | India
Job description
About The Role
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us as a Founder of our 'new' Sandoz! Job Purpose: Provides effective operational and regulatory support to Novartis as well as to regional/global organizations for assigned regulatory submission and maintenance activities, including preparation and submission of regulatory dossiers, maintenance of regulatory databases and archives and artwork-related activities. Your Key Responsibilities: Coordinates and prepares high quality submissions of regulatory dossiers for assigned products. Achieve the CTA/NDA submission on the targeted date; Achieve the approval of CTA, NDA and other related supplementary application on the targeted date. Ensure license renewal Submission and approval on time; Ensure CMC/BPI/PSUR/RMP in line with NMPA regulation and Novartis internal policies; Ensure registration master file update. Assist to coordinate f2f meeting with CFDA/CDE for new project discussion. Communicate the questions referred by HAs timely and smoothly. Timely update and communicate the registration status to the line manager. Timely order and tracking the registration sample, dossier, certificates. Provide regulatory support for other functions (marketing, medical, sales, MA&C, TechOps. Start to establish good communication and relationship with key stake holders. Get familiar and with company and department SOP and working procedures. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt. Distribution of marketing samples (where applicable) Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve. Role Requirements What you'll bring to the role:Job tags
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