Preparation of regulatory monitor and market intelligence data. Analyse and share market intelligence data and preparation of regulatory monitor capturing key regulatory developments on monthly basis.
Preparation and submission of post approval variations and send proper communication for implementation of the change. Co-ordination with GRA, Country regulatory affiliates and COE for submission of dossier and supporting the required documentations.
Assess the performance of external manufacturing partners, identify opportunities for improvement. Ongoing performance tracking for external manufacturing, including quality, cost, delivery, and efficiency. Ensure the alignment of external sites with Teva expectations
Method Development, Method Validation, Method Verification of DS, DP as per In -House and monograph methods. Testing of analytical samples by using HPLC, GC, Dissolution, AAS, Titrations, Wet analysis.
Pre formulation studies of Pharmaceutical & Medicinal Devices and to check the compatibility of the API with different excipients. Formulation development of Pharmaceutical & Medicinal Devices
Achieve monthly, quarterly, half yearly and yearly sales target by promoting companys products ethically to customers as per the business plan, also ensure Doctor, Customer Call average as per the customer management plan of the division
Responsible for processing of Individual Case Safety Reports ICSRs from various sources, Literature search and review, signal detection and management, tracking regulatory information, performing regulatory submissions and supporting preparation of aggregate and other study reports, as well as Medical and Product Dictionary Management activities, where applicable
Expertise in Nitrosamine and elemental impurities and recent regulatory updates. Handling of analytical instruments e.g. HPLC, UPLC, UV, KF, Particle Size, Dissolution, LCMS, GCMS, ICPMS and Zetasizer. Expertise in Analytical Method Development Assay/ RS/CU/ Dissolution and report writing.