Genpact (NYSE : G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose – the relentless pursuit of a world that works better for people – we serve and transform leading enterprises, including the Fortune Global 500, with our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI.
Inviting applications for the role of Labelling- Manager-English-Hybrid Munchen.
This project is staff support to a large client, filling in as a member for their team in lieu of their own. This program is intended to support client in their requested requirement for regulatory submissions that may have impact on registrations of small molecules, biologics, and combination products.
Responsibilities
1. Leading a cross-functional team in case of Company Core Documents (CCDs) impact assessments or presentations to governance body.
2. Preparation and submission of EU PIs (MRP / DCP, CAPs) for Urgency Level updates (specific timelines will be issued per case).
3. Providing strategic inputs for all labeling tasks.
4. Worldwide contact person for Labelling topics.
5. Assessing deviations of local labels from CCDs.
6. Understanding regulatory implications of product strategy with regards to the product label, assessment, and practical management of associated impacts.
7. Supporting and coordinating audit and inspection related activities.
8. In case of an update, in collaboration with the cross-functional team, propose labelling updates, prepare documentation needed, including respective internal presentations ready to be shared with releasing governance body for labelling content.
9. Prior to seeking release at Client governance body, brief respective Client colleague from Global Labelling about the labelling strategy and content.
10. In case of MRP / DCP or centrally approved (CAP) products, prepare respective EU Product Information (PI) for submission in EU via internal standard process.
11. Collaborate closely with respective stakeholders.
12. Dispatch CCDs worldwide via internal standard process(es).
13. Assess deviations of local labels from CCDs via internal standard process in collaboration with external supplier and the internal cross-functional team.
14. Maintain Information Management (RIM) Database for Labelling workflows CCDs dispatches, for EU CAP products and for worldwide registrations as part of Deviation Management process.
15. Document labelling activities in line with internal standard process.
16. Worldwide contact person for Labelling topics affecting the product, including preparation of responses to Health Authority / Device Registration Body requests and to deficiency letters for Labelling in close collaboration with the cross-functional team.
17. Supporting and coordinating audit and inspection related activities.
18. Maintaining up-to-date knowledge of regulatory requirements and guidelines.
19. Provide regular progress reports and updates to internal Global Labeling governance colleague.
20. Acting and living Client specific roles, processes, and systems.
Qualifications we seek in you!
Minimum Qualifications / Skills
At least Bachelor's degree required in Pharmaceutical science, engineering, or related field (advanced degree preferred).
Preferred Qualifications / Skills
Relevant experience in Labelling tasks and related aspects.
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