Regulatory Compliance Specialist
2 weeks ago
Job Overview
The successful candidate will be responsible for managing and overseeing regulatory submissions, ensuring compliance with relevant regulations and guidelines.
- Develop and implement effective strategies for regulatory submissions, taking into account regional specific requirements.
- Lead the preparation and contribute to briefing packages for HA meetings associated with established products, supporting scientists as required.
- Responsible for regulatory submissions such as new license applications, renewal applications, change applications, PSUR submissions, and international Scientific Advice meetings.
- Coordinate and dispatch responses to HA questions in a timely manner, as applicable.
- Regulatory Submissions Management
- Briefing Package Preparation
- Scientific Advice Meetings
- HA Question Responses
- At least 3+ years of regulatory experience in a regulatory authority facing role, supported by additional pharmaceutical/industry experience.
- Understanding of scientific principles and technical requirements relevant to the development of a pharmaceutical product.
- Strategic and tactical thinking ability, complemented by a
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