Manager - Regulatory Affairs
Genpact
5 - 10 years
Mumbai
Posted: 06/06/2025
Job Description
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..
About Company
Genpact is a global professional services firm that offers a wide range of digital transformation services and solutions. With a presence in over 30 countries, Genpact leverages its deep domain expertise in operations and analytics to help businesses transform their operations, improve efficiency, and enhance customer experience. The company combines digital technology, data science, and operational excellence to deliver business outcomes across various industries, including banking, insurance, manufacturing, and healthcare. Founded in 1997 as a subsidiary of GE, Genpact has grown into an independent, NYSE-listed company with a diverse workforce of over 90,000 employees globally.
Services you might be interested in
One-Shot Campaign
Reach out to ideal employees in one shot!
The intelligent campaign for reaching out to the ideal audience to whom you can ask for help (guidance or referral).