Executive

JOB RESPONSIBILITIES

Management of New submission and approvals of North Africa (MENA) and South Africa. •Review of Compilation and submission of registration and re-registration, Variation in USA, LATAM, MENA and South Africa.•Submission of Post approval variation in above regions. •Precisely review strategy and communicate with Counter department such as Research and development, Manufacturing site, CSBU, USBU and ISBU team. •Tracks and maintenance of regulatory database.•Review and approval of change controls, SAP and order execution activity. •Tracks and Monitor of regulatory submission, approval and website updation related to regulatory •To ensure, support and Coordinate with the USBU, CSBU, ISBU and internal departments through various activities like preparation of Registration dossiers , Re-registration dossiers, Submission of Supplements/Variations, Query response, Initiation and review of Change Controls, Creation & Maintenance of Regulatory Database and any other assignments as specified by the reporting authority for Latin America (Region VI) , South Africa & MENA countries. •To plan, prioritize and allocate the projects to subordinates. •To monitor the technology transfer documents like method verification/ transfer protocol and report, raw material specification, packaging material specification, finished product specification, stability protocol. •To review Technology Transfer documents for commercial batches and export order authorization. •To manage changes with reference to variation, data management, pharmacopoeial updating, re-registration and annual reports.