Job for M.Pharm, M.Sc as Senior Regulatory Submission Publisher at Novartis
Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Sr Regulatory Submission Publisher - II
• Liaises with responsible Regulatory Submission Publishers and other personnel for planning, compilation, and publishing of final submissions. Actively works with the Regulatory Affairs Project Managers, therapeutic areas, and line function representatives to ensure Health Authority (HA) deadlines are met and provides expert advice and guidance to project teams regarding general content and format of Regulatory submissions.
• Serves as the lead publisher on major submissions as directed.
• Produces high-quality dossiers by handling the collection of components, publishing / assembly, quality review, and delivery of submissions in paper and electronic format. For paper submissions, creates cross-references, tables of content, tab / slip sheets, and volumes. For electronic submissions, performs bookmarking, hyperlinking, and tables of content creation according to HA guidelines.
• Publishes Regulatory documents with state-of-the-art software applications in the Novartis Development environment according to internal processes and agreed-upon timelines.
• Shares accountability with Regulatory Affairs Project / Senior Project Manager and respective DRA TA / BU manager(s) to ensure proper organization of a timely submission. Encourages open and productive communication within DRA and the project teams.
• Proactively troubleshoots technical / quality issues related to the preparation and dispatch of submissions. Liaises with counterparts and applicable line functions (e.g., DiT, Cl
• Masters Degree in Science or Pharmacy
• Min. 5 years of experience in relevant area
• Active command in English with excellent written and spoken communication skills
Experience : 5 years
Qualification : M.Sc, M.Pharm
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 20th May, 2019
See All Other Jobs in our Database