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:
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

Qualifications we seek in you
Minimum Qualifications / Skills
Atleast Bachelors 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.