Regulatory Affairs - Translation management, artwork review and change management Analyst

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 Translation management, artwork review and change management Analyst In this role you will ensure that changes required through DCIs are properly implemented in the SCF and that there are no discrepancies with the approved artwork. Responsibilities Ensure that changes required through DCIs are properly implemented in the SCF and that there are no differences against the approved artwork. Ensure that the changes in SCF are related to LRAM’s DCI request, additional changes received in SCF comply with the regulation. In multi-country presentation, evaluate the impact of the changes to the countries involved. If applicable, align alternative solutions with the LRAMs of the affected countries. Develop the implementation plan together with the LCM. Utilization of software and systems like SAP, Veeva Vault, TVT Backup for the translation management activities Translation management activities for LATAM countries Coordination of dossier translation including retrieving and processing editable documents for translation Coordination of translation for maintenance events, renewals, CMC, CCDS Technical validation of received documentation and translated documents (including formatting, excluding subject matter/content check) Maintain traceability trackers Qualifications Minimum Qualifications Experience in regulatory affairs with must knowledge of current guidelines in LATAM Market. Bachelor’s degree, preferably in Pharmacy, Medicine, Chemistry, or related Life science discipline required with relevant experience in the pharmaceutical industry. Mandatory Knowledge of Regulations for the LATAM market. Should be advanced level in English language Preferred Qualifications Ensure adherence to the specific project specifications or standards throughout the lifecycle of the submission. Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously. Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviors to drive high quality deliverables. Demonstrates the ability to independently solve trouble shoot problems that arise within job responsibilities and expectations and takes a new perspective using existing solutions. Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation and process. Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures. Depending on experience level, mentor newly hired staff or lead a team of junior staff. Flexibility in responding to changing priorities or dealing with unexpected events. Capability to handle multiple priorities and balance work to achieve business goals. Come 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 'starter kit,' paying to apply, or purchasing equipment or training.