Manager - Regulatory Affairs
Genpact
5 - 10 years
Mumbai
Posted: 06/06/2025
Job Description
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:
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.
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.
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).