Senior Regulatory Programs Manager
1 month ago
At SENIOR SPIRIT OF ROSELLE PARK, 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 play a critical role in developing and implementing the global regulatory strategy for our programs.
Key Responsibilities:
- Develop and implement global regulatory strategies for programs through development, registration, and post-approval in assigned regions.
- Provide input to global program regulatory strategy, including regulatory designations and innovative approaches.
- Coordinate regulatory readiness with other line functions, country organizations, and regions.
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.
- Compliance and quality mindset.
- Fluency in English.
About Us:
At SENIOR SPIRIT OF ROSELLE PARK, 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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