Safety & Labelling Partner Lead
hace 12 horas
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 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 & ACCOUNTABILITIESCreate and facilitate the 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 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 of 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).Act as deputy for the Head of Global Labelling.Co-ordinate labelling queries and provide guidance on regulatory labelling requirements.Lead review of RMPs/PSURs activities.Contribute to the continuous improvement of the end to end labelling process, update Standard Operating Procedures, Work Instructions and supporting documents as required.Work with the Head of Global Labelling in regulatory labelling intelligence activities, including researching labelling across different markets and promoting best labelling practices.Regular management of reporting, ensuring data integrity is met and changes are on track for being delivered, resolve roadblocks proactively and escalate to the Head of Global Labelling where required.Oversee and contribute to the maintenance of all regulatory data in the relevant systems and tools in a timely manner for reporting and effectiveness checks.Requirements:Excellent verbal and written communication skills, especially suitable for labelling.Excellent interpersonal skills.Strong attention to detail required, especially for labelling revisions.Adaptable to change in business needs, proven ability to prioritise and organise plans.Work collaboratively and effectively both within RA, cross functionally and with external partners.Aspire to continuously develop technical/professional knowledge and interpersonal/management expertise.Fluency in English as a business language.Well-developed proven experience with EU and worldwide regulatory labelling requirements, and managing labelling submissions and related activities.Experience with global labelling processes and management of Company Core Data Sheets.Project and programme management experience.Working knowledge in safety label changes.Benefits vary between locations.Anti-discrimination and equal opportunities:Norgine prides itself on its integrity, honesty and fairness in all aspects of our business.
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