Lead Associate - Regulatory Affairs

Ready to shape the future of work
At Genpact, we don't just adapt to change-we drive it. AI and digital innovation are redefining industries, and we're leading the charge. Genpact's AI Gigafactory, our industry-first accelerator, is an example of how we're scaling advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. From large-scale models to agentic AI, our breakthrough solutions tackle companies most complex challenges.If you thrive in a fast-moving, tech-driven environment, love solving real-world problems, and want to be part of a team that's shaping the future, this is your moment.Genpact (NYSE: G) is an advanced technology services and solutions company that delivers lasting value for leading enterprises globally. Through our deep business knowledge, operational excellence, and cutting-edge solutions - we help companies across industries get ahead and stay ahead. Powered by curiosity, courage, and innovation, our teams implement data, technology, and AI to create tomorrow, today. Get to know us at genpact.com and on LinkedIn, X, YouTube, and Facebook.Inviting applications for the role of Lead Associate, EU CoTIn this role, Coordination of Translation: The Translation Coordinator/Planner is responsible to provide regulatory project management and support for EU labelling submissions.ResponsibilitiesPrimary Operational Activities (include but are not limited to):Acknowledge COT request of RAE within stipulated timeline..Perform anonymization of the track changes in EN PI and upload in RAE domain..Update REDS properties of EN PIs to move from EU LL domain to RAE domain.Initiate Round of Translations for 24 EU PI languages..Coordination with respective EU CRAs for their queries and resolution..Submission of all proposed EU PIs stored in REDS to EU Member States on Day+5..Coordination of notification email to EU CRAs for implementation of member state comments into their pertinent language files (24)..QC check and submission of all proposed language files stored in REDS to EMA on Day +25 along with QRD form 2 and Checklist..Create non-eCTD submission ID for submissions to HA in RADR within specific product application. Archive files and folders related to submissions to HA which includes CHMP timetable, Day +5 package, linguistic review comment emails, and Day +25 package..Post approval activities: Closing sequence by changing approval dates in the document status of all language versions in REDS, communication of approval with final Doc IDs to CRAs, review of files on the Community register & EPAR via GlobalVision TVT check, inform to CRAs to check their language files on EPAR.

EU Regional QC: The EU Regional QC Specialist will handle the outsourced procedures on MSD RAE behalf and in compliance with MSD SOPs and processes.
The EU Regional QC Specialist is responsible for:.Perform review activities for EU Regional Product Information (RPI) - including Prescribing Information (EU PI) & Patient Information Leaflet (EU PIL), & Annex-As as appropriate for submission and prior to artwork creation to include Proofreading, formatting, alignment to regional templates, client reference guide, and QC of EU translation labeling documents to be in line with Translation QC process..Execute quality check to ensure all changes in the EN PI/PIL/Annex-A, included using track changes tool, are implemented in all EU local languages PIs.No content check is requested unless specifically mentioned in the Regional Quality Checklist..Coordination with CRA for implementation of member state comments into their pertinent language files (24).To check, if CRA who had comments have posted their checklists with feedback in SharePoint. If not, send reminder mail to CRAs..Maintenance of 24 Translation QC Checklists in Client SharePoint (ZIP file - all languages)Qualifications we seek in you!Minimum Qualifications.Bachelor's Degree or higher in life sciences field.3-6 years working experience in the pharmaceutical regulatory affairs area and in particular in EU regulatory frameworkPreferred Qualifications/ Skills.Knowledge of the procedural details of EU regulatory submissions.Working experience in the EU linguistic review process for Centralised Products.Implementation QRD conventions and standard terms.Experience using regulatory document management systems.Solid knowledge of Microsoft Office applications (Word, Excel, Outlook).Why join Genpact.Be a transformation leader - Work at the cutting edge of AI, automation, and digital innovation.Make an impact - Drive change for global enterprises and solve business challenges that matter.Accelerate your career - Get hands-on experience, mentorship, and continuous learning opportunities.Work with the best - Join 140,000+ bold thinkers and problem-solvers who push boundaries every day.Thrive in a values-driven culture - Our courage, curiosity, and incisiveness - built on a foundation of integrity and inclusion - allow your ideas to fuel progressCome join the tech shapers and growth makers at Genpact and take your career in the only direction that matters: Up.Let's build tomorrow together.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 respect and integrity, customer focus, and innovation. 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 %27starter kit,%27 paying to apply, or purchasing equipment or training.