Senior Regulatory Labelling Specialist
hace 21 horas
Empresa Reconocida is a leading healthcare organisation that transforms lives with innovative solutions. We are seeking a talented individual to join our team as a Senior Regulatory Labelling Specialist in any of our sites.
About the RoleThis is an exciting opportunity for a highly skilled and experienced professional to lead our labelling activities and ensure compliance with regulatory standards. As a key member of our team, you will be responsible for providing strategic and operational labelling input, working closely with our Regulatory Service Providers and Head of Global Labelling.
The ideal candidate will have a strong background in labelling regulations and experience in managing QC checks, creating meeting minutes, and overseeing approvals of core labelling documentation. If you are passionate about delivering high-quality work and contributing to a dynamic team, we encourage you to apply.
Key Responsibilities and Accountabilities- Create and facilitate meeting minutes at the Patient Safety & Labelling Committee meeting
- Manage QC checks of labelling documents following endorsement at Patient Safety & Labelling Committee prior to approval by the Head of Global Labelling
- Provide strategic labelling and operational regulatory input, working closely with Regulatory Service Providers and Head of Global Labelling
- Chair the Safety & Labelling Change Meeting, ensuring timely implementation of global labelling changes in national labels
- Oversee approvals of core labelling documentation using Norgine systems
- Responsible for communication, check-up, and oversight of regulatory submissions following updates to core labelling documentation
- Work independently to ensure safety-related regulatory activities are planned, agreed, and progressed within procedural timeframes
We offer a competitive salary of $80,000 per year, reflecting your skills and experience. Additionally, you will have access to ongoing development and upskilling opportunities, a long-term career with a sense of belonging, and a company that cares about people's wellness.
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