Manager - Regulatory Affairs
Manager - Regulatory Affairs
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Ready to build the future with AI
At Genpact we dont just keep up with technologywe set the pace. AI and digital innovation are redefining industries and were leading the charge. Genpacts AI Gigafactory our industry-first accelerator is an example of how were 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 innovation-driven environment love building and deploying cutting-edge AI solutions and want to push the boundaries of whats possible this is your moment.
Genpact (NYSE: G) is anadvanced technology services and solutions company that deliverslastingvalue for leading ourdeep business knowledge operational excellence and cutting-edge solutions we help companies across industries get ahead and stay by curiosity courage and innovationour teamsimplementdata technology and AItocreate tomorrow to know us onLinkedInXYouTube andFacebook.
Inviting applications for the role of ManagerBusiness Analyst Regulatory/RIMS
We are seeking a Business Analyst (BA) 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 Bachelors 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
Lead AI-first transformation Build and scale AI solutions that redefine industries
Make an impact Drive change for global enterprises and solve business challenges that matter
Accelerate your careerGain hands-on experience world-class training mentorship and AI certifications to advance your skills
Grow with the best Learn from top engineers data scientists and AI experts in a dynamic fast-moving workplace
Committed to ethical AI Work in an environment where governance transparency and security are at the core of everything we build
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 140000 coders tech shapers and growth makers at Genpact and take your career in the only direction that matters: Up.
Lets 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.
Required Experience:
Manager
Employment Type
Full-Time
