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 Sub Publisher I
Job Description:
A individual contributor position in Drug Regulatory Affairs Operations (located in the US, Switzerland and India) accountable for all Publishing, verification, dispatch and management of submission dossiers for all (investigational, marketing au-thorization, lifecycle management, post approval change management) NVS drug dossiers (e-CTD, NEES, Paper). Participates and supports implementation of various DRA Operations strategic initiatives and business process improvements further enhancing core business processes resulting in cycle time reduction and enhanced compliance.
• 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 direct supervision and with mentoring 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
• Supports implementation of Technical Format requirements and collaborates with DRA Operations Submission Standards and Strategy team members to develop a company business guidance on publishing deliverables
• 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.
• Partner with LF (Clinical, Preclinical, Research and Technical) Coordinators (or designee) to negotiate every submission component target date with the goal of achieving the target submission date for minor submissions.
• 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 1-2 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:
Job ID: 151107BR
Experience: 1-2 Years
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: R&D
End Date: 10th July, 2015
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