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Global Program Regulatory Director
vor 1 Monat
Major accountabilities:
- In collaboration, develop high quality global regulatory strategies related to Medical Devices & IVDs.
- Evaluate and communicate potential regulatory risks and develop mitigation strategies for the program.
- Leverage regional expertise for global regulatory strategies and Health Authorities engagement, focusing on EU and ROW.
- Provide strategic regulatory input on key documents and lead execution of the regulatory strategy including submission planning and critical review.
- Lead interactions with management and external consultants for strategic input on regulatory strategies.
- Provide input on BD&L Due Diligence evaluations and may serve as local HA liaison.
Key performance indicators:
- Timely submission of high-quality dossiers
- Organizational alignment and risk awareness
- High performing subteams
- Compliance with external and internal requirements.
Minimum Requirements:
Work Experience:
- Approximately ≥8 years of regulatory and pharmaceutical development experience
- Leadership experience in global regulatory and pharmaceutical development activities
- Strong interpersonal, communication, influencing and problem-solving skills.
- Adept at navigating organizational complexity.
Skills:
- Deep knowledge of global regulations for Medical Devices, Drug/Device Combination Products and IVDs.
- Interpretation and application of regulations and guidance.
- Regulatory submissions and post-marketing strategies.
- Understanding of Regulatory operations.
Languages:
- Fluency in English as a business language. Additional language skills are an asset.
Why Join Us: Collaborating with smart, passionate individuals to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
Novartis is committed to fostering an inclusive work environment and diverse teams.
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