Job Description

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 xe2x80x93 the relentless pursuit of a world that works better for people xe2x80x93 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 Lead Consultant, Regulatory Affairs!
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:
xefx82xa7 Leading a cross functional team in case of Company Core Documents (CCDs) impact assessments or and presentation to governance body
xefx82xa7 Preparation and submission of EU PIs (MRP/DCP, CAPs) for Urgency Level updates (specific timelines will be issued per case).
xefx82xa7 Provides strategic inputs for all labelling tasks
xefx82xa7 Worldwide contact person for Labelling topics
xefx82xa7 Assess deviations of local labels from CCDs
xefx82xa7 Understand regulatory implications of product strategy with regards to the product label, assessment and practical management of associated impacts.
xefx82xa7 Support and coordinate audit and inspection related activities
xefx82xa7 In case of an update
xefx82xa7 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
xefx82xa7 prior to seeking release at Client governance body, brief respective Client colleague from Global Labelling about the labelling strategy and content
xefx82xa7 in case of MRP/DCP or centrally approved (CAP) products, prepare respective EU Product Information (PI for submission in EU via internal standard process
xefx82xa7 collaborate closely with respective stakeholders
xefx82xa7 dispatch CCDs worldwide via internal standard process(es)xefx82xa7 Assessing deviations of local labels from CCDs via internal standard process in collaboration with external supplier and the internal cross functional team
xefx82xa7 Maintaining Information Management (RIM) Database for Labelling workflows CCDs dispatches, for EU CAP products and for worldwide registrations as part of Deviation Management process
xefx82xa7 Documenting labelling activities in line with internal standard process
xefx82xa7 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
xefx82xa7 Supporting and coordinating of audit and inspection related activities
xefx82xa7 Maintaining up-to-date knowledge of regulatory requirements and guidelines
xefx82xa7 Provide regular progress reports and updates to internal Global Labelling governance colleague
xefx82xa7 Acting and living Client specific roles, processes, and systemsQualifications we seek in you!
Minimum Qualifications / Skills
Atleast Bachelor's degree required in for Pharmaceutical: science, engineering, or related field (advanced degree preferred).
Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. Get to know us at genpact.com and on LinkedIn, X, YouTube, and Facebook.
Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a 'starter kit,' paying to apply, or purchasing equipment or training.

Genpact