Regulatory Strategy and Compliance Expert
2 weeks ago
We are seeking a highly skilled Regulatory Strategy and Compliance Expert to join our team at Novartis. As a Global Program Regulatory Manager, you will play a key role in developing and implementing the global regulatory strategy for programs through development, registration, and post-approval in assigned regions.
Key Responsibilities- Regulatory Strategy: Contribute to the development of global program regulatory strategy, including innovative approaches and regulatory designations.
- Coordinate regulatory readiness with other line functions, country organizations, and regions, representing RA or leading in regional or cross-functional teams.
- Develop and maintain key documents, determine requirements, and coordinate HA interactions.
- A science-based bachelor's degree with an understanding of pharmaceutical development and clinical trials.
- Track record of involvement in regulatory or pharmaceutical development in one or more major regions.
- Strong interpersonal skills and experience working in complex, cross-functional organizations and leading cross-functional teams.
- Compliance and quality mindset.
- Fluency in English.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Our company is driven by a passion to reimagine medicine and improve people's lives. With a focus on innovation and collaboration, we strive to bring our medicines to patients faster.
The estimated salary for this position is $115,000 - $145,000 per year, depending on location and experience.
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