At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.
We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.
Bring everything about yourself that you're proud of, whether that's your passion for making a difference, focus on others' well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community.
In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people's wellness as much as you do.
Because at Norgine, we transform lives with innovative healthcare solutions.
We have an exciting opportunity for a Safety & Labelling Partner Lead to join Norgine in any Norgine sites.
The person holding this position will report to the Head of Global Labelling.
The Safety & Labelling Partner Lead provides strategic and operational labelling input and leads and oversees activities with the Regulatory Service Provider(s) to ensure the product labelling meets all applicable standards and regulations.
If you want a multi-dimensional 3D career in a leading healthcare organisation, join us.
KEY RESPONSIBILITIES & ACCOUNTABILITIES
• Create and facilitate the meeting minutes at the Patient Safety & Labelling Committee meeting.
• Manage QC checks of labelling documents following endorsement at the Patient Safety & Labelling Committee prior to approval by the Head of Global Labelling.
• Provide strategic labelling and operational regulatory input and work in close collaboration with Regulatory Service Provider(s) and Head of Global Labelling in maintaining compliant and competitive up-to-date labelling information, and track market-specific variances in line with Norgine procedures.
• Manage the CCDS maintenance calendar.
• Interact with Regulatory Service Provider(s) to manage timely implementation of global labelling changes in national labels, ensuring international consistency and compliance with the CCDS.
• Chair the Safety & Labelling Change Meeting, managing information flow for execution to Regulatory Service Provider(s).
• Oversee the approvals of core labelling documentation using Norgine systems to ensure transparency and accuracy of change.
• Responsible for the communication, check-up and oversight of regulatory submissions following updates to core labelling documentation in line with Norgine procedures.
• Work in an independent manner to ensure safety-related regulatory activities are planned, agreed and progressed so that procedural timeframes are met.
• Manage, track and update spreadsheets for labelling activities and generate metrics and report accordingly.
• Contribute to the Regulatory Service Provider(s) governance meetings by raising topics for resolution.
• Track and coordinate the progress of Regulatory Labelling Compliance activities (e.g.
deviations, CAPAs).
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