A global healthcare leader, 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 : Regulatory Submission Publisher-I
Job Description
Global Submission Publishing of all submissions from a Global perspective and dispatches to worldwide Health Authorities (FDA, EMA, LATAM, ROW). Accountable for all Publishing, verification, dispatch and management of submission dossiers for all (investigational, marketing authorization, lifecycle management, post approval change management) NVS drug dos-siers (e-CTD, NEES, Paper) under limited or no supervision and with men-toring by supervisor
• Liaises with a team of Publishers located in EH, Switzerland and India. Works in a global capacity with colleagues across these regions. Support the rest of the global publishing team and other temporarily assigned staff in preparation, quality review, and timely dispatch of drug dossiers
• Works in close collaboration with the Franchise Head of Global Submission Publishing and Global Submission manager, assigned to respective franchise/activity with clear accountability for publishing process
• Provides strategic and operational expertise to teams for routine or maintenance submissions to ensure the timely, quality preparation and execution for electronic and paper submissions to Global Health Authorities (EMA, FDA, Swiss Medic, LATAM, ROW) • Responsible for managing all aspects related to the preparation, tracking, compilation, publishing and technical quality control of all assigned maintenance regulatory submissions for assigned franchise. Ensure adher-ence to internal standards and processes, as well as Health Authority’s re-quirements.
• Reports and updates Franchise Head for Submission Publishing on submis-sion progress. Provide monthly report to FH-GSP, and line management within DRA Ops. Identify issues and solutions relating to timing, quality and resources.
Candidate Profile
BS or MS or with comparable relevant experience and demonstrated capability.. Fluency in English as a business language. Additional language is an asset 2-4 years of experience in the pharmaceutical industry, with relevant experience in electronic submission publishing, dossier management and dispatch of global drug dossiers (US, EU, Asia, Latin America, etc). Working knowledge of HA submission publishing requirements globally. Knowledge, of Regulatory Business processes and related tools (document management, publishing, etc. Excellent verbal and written communication skills. Proven negotiation skills.
Additional Information:
Experience: 2-4 years
Qualification : BS or MS
Location : Hyderabad
Industry Type: Pharma
Functional Area: R&D
Job ID: 243880BR
Last Date: 21st July, 2018
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