September 14, 2016

Global Program Regulatory Manager / Associate Director

Novartis Oncology - Cambridge, MA

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  • Company
    Novartis Oncology Novartis Oncology
  • Location
    Cambridge, MA
  • Job Type
  • Job Classification
    Full Time
  • Experience
    Entry Level (0 - 2 years)
  • Company Ref #
  • AJE Ref #

Job Description

The Global Program Regulatory Manager / Associate Director works with some independence under limited supervision to provide strategic and operational regulatory direction and may support the GPRD for programs through development, registration and approval/post approval. The GPRM ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the GPRD. In certain cases, the GPRM may act as the GPT representative. The GPRM is a member of the DRA subteam and may indirectly report to the GPRD for the project and may have responsibility for leading regional DRA subteams. br br Responsibilities: br br Regulatory Strategy br br • Responsible for implementing regulatory strategy and managing operational activities for assigned regions. br br • Provides input into global regulatory strategy and, including identification of gaps or risks in global strategic plan for assigned regions. br br • Partners with regions to align on regulatory strategy in order to fullfill business objectives. br br • Works with GPRD to plan and facilitate presentations to Novartis regulatory boards on regulatory strategy br br • Coordinates and implements regulatory readiness with other line functions, Country Pharma Organizations and key opinion leaders. br br • Works with GPRD to interact with regulatory consultants/advisors for strategy input and challenge. br br • Represents DRA on or leads sub-teams as required. br br HA Interactions br br • Determines requirements and sets objectives for Health Authority (HA) interactions with GPRD br br • Interacts directly with HAs as appropriate in meetings with GPRD br br • Coordinates and plans rehearsals for HA meetings. br br • Facilitates preparation and finalization of briefing books. br br • Develops and implements plans for timely response to HA requests and coordinates responses. br br • May serve as local HA liaison depending on location (e.g., FDA or EMA). br br Submissions and Approvals br br • Responsible for integrating global strategy into regional submissions worldwide. br br • Contributes to identification of issues, gaps, and tradeoffs affecting optimal and timely submission and approval. br br • Coordinates, plans, and prepares for submission of dossiers in assigned regions worldwide. br br • Review of global dossier summary documents. br br • Contributes to development and implementation of plans to avoid/minimize clock stops during submission review. br br • Responsible for submission of Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs). br br • Participates in negotiations for approvals as required with GPRD br br • Responsible for facilitating timely submission and approval of dossiers with br br HAs under the guidance of the GPRD. br br Prescribing Information br Contributes to the development of the Development Core Data Sheet (DCDS) and Core Data Sheet (CDS) with GPRD, consistent with development data and commercial objectives of the TPP. br Assists with generating local PIs and ensuring that they are integrated with the CDS, TPP and regulatory strategy, and are commercially competitive. br Contributes to identifying potential label issues/gaps and develops regulatory label negotiation strategy with contingency planning. br br 2 br Revise labels as needed to achieve timely HA approval with best possible label based on available data. br Responsible for ensuring necessary updates or required reviews of local labeling and to capture deviations to maintain alignment with the CDS in conjunction with DRA GL. br br Regional Excellence and Compliance br Responsible for finalization and on time submission of annual reports and renewals across assigned regions. br Responsible for appropriate entering and quality of product specific attributes in compliance database. br Ensures regulatory compliance for assigned project and keeps records of all major HA interactions in the validated document management system. br Ensures quality and compliance with global regulatory requirements (regions responsible) and adherence to regulatory internal policies and processes. br Provide support as needed for non-project related regional excellence activities. br br b EEO Statement /b br The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. br