Manager - 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 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 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 and on and Inviting applications for the role of Manager Business Analyst - Regulatory RIMS Data Migration and Transformation We are seeking a detail-oriented and proactive Project Lead to support a global Regulatory Data Transformation and Readiness initiative within the pharmaceutical domain This role is responsible for managing end-to-end regulatory data initiatives driving Veeva Vault configuration readiness and ensuring alignment with compliance frameworks such as IDMP Identification of Medicinal Products and PMS Product Management Service The successful candidate will coordinate cross-functional efforts to enable high-quality governed data for regulatory submissions and operational excellence Responsibilities Gap Assessment Remediation o Lead comprehensive gap assessments against regulatory data standards and business needs o Participate in the design and implementation of remediation strategies to close identified gaps Cross-Functional Coordination o Serve as the liaison between business stakeholders regulatory teams and IT for Marketing Authorization MA preparation o Analyze impacts of data transformation on Veeva Vault configuration and ensure smooth integration across systems Data Profiling Governance o Oversee and perform hands-on data profiling and validation aligned with global regulatory standards e g IDMP-PMS RMS o Recommend and help implement data governance best practices to improve data quality and consistency Training Readiness o Plan and manage training programs identify user training needs and coordinate development of knowledge assets o Deliver end-user training sessions and ensure collaboration with Change Communications teams for adoption readiness System Optimization Metrics o Monitor system usage trends track key performance metrics within Veeva Vault and suggest continuous improvements o Communicate data and process enhancement opportunities to stakeholders and drive implementation of improvement initiatives Regulatory Compliance Alignment o Ensure the system aligns with global regulatory standards GxP 21 CFR Part 11 IDMP xEVMPD etc o Provide business insights on regulatory submissions dossier management and health authority interactions o Identify areas for process improvement and compliance enhancement Life Sciences Regulatory Domain Knowledge Compliance Alignment o Strong knowledge of pharmaceutical regulatory information management system RIMS including Product management Registration process Submissions Health Authority interactions FDA EMA MHRA etc Dossier management and archiving Document Management Experience with global regulatory compliance standards such as o GxP 21 CFR Part 11 IDMP xEVMPD o Regulatory submission tracking and change control processes o Provide recommendations for business process improvements and regulatory compliance enhancements General tasks Lead and support regulatory data readiness and transformation efforts across business and technical domains Ensure alignment of data structures and system configurations e g Veeva Vault with evolving global regulatory standards Coordinate cross-functional teams to assess remediate and optimize data for regulatory submissions and compliance Drive improvements in data governance system integration training and user readiness to support a successful transformation journey Act as a bridge between Regulatory Affairs IT and Change Management teams to ensure timely and effective project execution Experience 8 years of experience as a Business Analyst in Life Sciences Regulatory domain Pharma Biotech Hands-on experience with Veeva Vault RIM modules Registrations Submissions Submissions Archive etc Knowledge of regulatory submission processes dossier management and compliance requirements Hands-on experience with data profiling enrichment and validation tools Experience in system integration and data migration projects within regulatory frameworks Understanding of business process optimization data standards and automation in regulatory operations Qualifications we seek in you Minimum Qualifications Atleast Bachelor s degree required in for Pharmaceutical science engineering or related field advanced degree preferred Veeva Vault RIM certification is a plus Experience working in an Agile Scrum environment Language English 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 progress 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