Senior Regulatory Programs Manager
2 weeks ago
Our company is committed to delivering innovative solutions that improve people's lives. To achieve this, we need talented individuals like you to join our team. As a Senior Global Regulatory Manager, you will play a key role in developing and implementing the global regulatory strategy for our programs.
The successful candidate will have a strong understanding of pharmaceutical development and clinical trials, as well as experience working in a complex, cross-functional organization. You will be responsible for providing input to global program regulatory strategy, coordinating regulatory readiness with other line functions, and contributing to the development and maintenance of key documents.
Key Responsibilities:
- Develop and implement the global regulatory strategy 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.
- Contribute to the development and maintenance of key documents, including regulatory submissions and product information.
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 Join Us:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. If you are passionate about delivering innovative solutions that improve people's lives, we encourage you to apply for this exciting opportunity.
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