Lead Consultant, Regulatory Affairs

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 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