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
We are seeking a Manager: Business Analyst - Regulatory/RIMS with expertise in Veeva Vault RIM (Regulatory Information Management) implementation for pharmaceutical clients. The BA will be responsible for gathering business requirements, analyzing regulatory processes, defining system configurations, and ensuring seamless adoption of Veeva Vault. The role requires close collaboration with business stakeholders, IT teams, and Veeva consultants to optimize regulatory operations and compliance.
Responsibilities
Business Analysis & Requirement Gathering:
o Work with business users and regulatory stakeholders to understand requirements and pain points.
o Conduct discovery sessions, workshops, and gap analysis to define system needs.
o Document business processes, functional requirements, user stories, and use cases.
o Support data migration strategies by analyzing regulatory data and defining data mapping rules.
System Implementation & Configuration Support:
o Define metadata, document types, templates, and workflows in Veeva Vault.
o Work with IT teams and vendors to align Veeva Vault configurations with regulatory needs.
o Support integration between Veeva Vault and other enterprise systems (e.g., SAP, Salesforce, EDMS).
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:
Conduct requirement discussion workshop and collect requirements
Author user stories and acceptance criteria or functional or configuration specification
Coordinate with configuration team on implementation of user requirements
Coordinate with business team to define business processes
Experience:
Relevant 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.
Experience in system integration and data migration projects within regulatory frameworks.
Understanding of business process optimization 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.