Job Description

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.