Global Program Regulatory Director

Summary

The Global Program Regulatory Director (GPRD) Medical Device & IVD Excellence EU & ROW provides global regulatory leadership throughout the lifecycle of a development and/or marketed product program(s). Using prior education and experience, the GPRD Medical Device & IVD Excellence EU & ROW integrates multiple inputs from global Health Authorities, regional and functional stakeholders to create a coherent global regulatory strategy for MDs and IVDs that fulfills the Target Product Profile as well as commercial, access, exclusivity, and overall portfolio objectives. Responsible to identify regulatory opportunities, develop contingencies for potential issues and ensure execution of the regulatory strategy across regions. Further, the GPRD Medical Device & IVD Excellence EU & ROW leads high functioning global regulatory subteam(s), provides regulatory and development expertise for all aspects of program strategy and represents RA Medical Devices & Precision Medicine on program subteams. The GPRD Medical Device & IVD Excellence EU & ROW may represent the RA function on cross-functional initiatives and committees.

About the Role

Major accountabilities:

• In collaboration with multiple stakeholders, develop/document/communicate high quality global regulatory strategies and Health Authority interactions related to Medical Devices & IVDs to achieve optimal development and business objectives. 
• Evaluate and clearly communicate potential regulatory opportunities and risks for the overall program and develop mitigation strategies. 
• Leverage regional expertise on Medical Devices & and IVDs in defining and executing global regulatory strategies and Health Authorities engagement with special focus on EU and ROW. 
• Provide strategic regulatory input on key development, labeling and global promotional documents, obtaining line endorsement as appropriate. 
• Lead execution of the regulatory strategy on Medical Devices & and IVDs including submission planning, guidance to contributing authors and critical review of submission documentation including labeling and HA responses with special focus on EU and ROW. 
• Lead interactions with RA and Development Unit management and with external consultants for strategic input to regulatory strategies with special focus on EU and ROW.
• Provide strategic regulatory and development input on Medical Devices & IVDs into BD&L Due Diligence evaluations, as required.
• May serve as local HA liaison (e.g., EMA) and operationalize local regulatory strategy for Medical Devices & IVDs.

Key performance indicators:

• Creation and execution of regulatory strategy resulting in timely submission of high-quality dossiers that maximize probability of approvals
• Organizational alignment around strategy and awareness of risks and mitigations 
• High performing subteams 
• Compliance with external (e.g., Health Authority, NBOp) and internal requirements.

Minimum Requirements:
Work Experience:

• Approximately ≥8 years of regulatory and pharmaceutical development experience, ideally spanning activities in Phases I-IV. 
• Experience with regulatory strategy in most or all of the following areas: 
• Demonstrated leadership and accomplishment across a broad range of global regulatory and pharmaceutical development activities in the areas of Medical Devices, Drug/Device Combination Products and IVDs 
• Direct and matrix leadership, including demonstrated ability to provide feedback and coach subteam members 
• Strong interpersonal, communication, influencing and problem solving skills. 
• Effectively navigates organizational complexity to achieve results.

Skills:

• Deep knowledge and understanding of global regulation for Medical Devices, Drug/Device Combination Products and IVDs.
• Interpretation, feedback, guidance and application of laws and regulations.
• Interpretation and application of HA and NBOp guidance and feedback .
• HA and NBOp discussions and negotiations.
• Regulatory submissions; extensive involvement in major submissions desired.
• Post-marketing/brand optimization strategies and commercial awareness. 
• Deep understanding of Regulatory operations. 

Languages :

• Fluency in English as a business language. Additional language is an asset.

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