Lead Consultant, Regulatory Affairs!
Genpact
5 - 10 years
Mumbai
Posted: 4/15/2025
Job Description
Responsibilities
:Leading a cross functional team in case of Company Core Documents (CCDs) impact assessments or and presentation to governance body
Preparation and submission of EU PIs (MRP/DCP, CAPs) for Urgency Level updates (specific timelines will be issued per case).
Provides strategic inputs for all labelling tasks
Worldwide contact person for Labelling topics
Assess deviations of local labels from CCDs
Understand regulatory implications of product strategy with regards to the product label, assessment and practical management of associated impacts.
Support and coordinate audit and inspection related activities
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
prior to seeking release at Client governance body, brief respective Client colleague from Global Labelling about the labelling strategy and content
in case of MRP/DCP or centrally approved (CAP) products, prepare respective EU Product Information (PI for submission in EU via internal standard process
collaborate closely with respective stakeholders
dispatch CCDs worldwide via internal standard process(es)
Assessing deviations of local labels from CCDs via internal standard process in collaboration with external supplier and the internal cross functional team
Maintaining Information Management (RIM) Database for Labelling workflows CCDs dispatches, for EU CAP products and for worldwide registrations as part of Deviation Management process
Documenting labelling activities in line with internal standard process
Worldwide contact person for Labelling topics affecting the product, incl. preparation of responses to Health Authority / Device Registration Body requests and to deficiency letters for Labelling in close collaboration with the cross functional team
Supporting and coordinating of audit and inspection related activities
Maintaining up-to-date knowledge of regulatory requirements and guidelines
Provide regular progress reports and updates to internal Global Labelling governance colleague
Acting and living Client specific roles, processes, and systems
About Company
Genpact is a global professional services firm that offers a wide range of digital transformation services and solutions. With a presence in over 30 countries, Genpact leverages its deep domain expertise in operations and analytics to help businesses transform their operations, improve efficiency, and enhance customer experience. The company combines digital technology, data science, and operational excellence to deliver business outcomes across various industries, including banking, insurance, manufacturing, and healthcare. Founded in 1997 as a subsidiary of GE, Genpact has grown into an independent, NYSE-listed company with a diverse workforce of over 90,000 employees globally.
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