Senior Regulatory Programs Manager
1 month ago
Job Summary:
We are seeking a highly skilled Senior Global Program Regulatory Manager to join our team. As a key member of our Regulatory Affairs department, you will be responsible for developing and implementing the global regulatory strategy for programs through development, registration, and post-approval in assigned regions.
About the RoleKey Responsibilities:
- Develop and implement global regulatory strategy for programs, including regulatory designations and innovative approaches.
- Coordinate regulatory readiness with other line functions, country organizations, and regions, representing RA or leading in regional RA or cross-functional activities.
- Contribute to the development and maintenance of key documents, determine requirements, and coordinate HA interactions.
Requirements:
- Science-based bachelor's or advanced degree, plus advanced understanding of pharmaceutical development and clinical trials.
- Awareness of post-marketing/brand optimization strategy, with a track record of involvement in regulatory or pharmaceutical development in Phases I – IV, in multiple geographies.
- Strong interpersonal skills and experience working in a complex, cross-functional organization and leading cross-functional teams.
- Compliance and Quality mindset.
- Fluency in English.
Why Novartis:
At Novartis, we are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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