Summary
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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