SM-Regulatory Affairs

Genpact; Mumbai; On-site; INR 15,00,000 - 25,00,000; Full time

Job summary

A leading technology services firm in Mumbai is seeking a Senior Manager in Regulatory Affairs to drive projects and stakeholder engagement. The role involves managing compliance frameworks, leading system configurations, and maintaining documentation. Ideal candidates will hold a Bachelor’s degree in relevant life sciences and have experience in the pharmaceutical industry. Join the team to shape the future through innovation and technology.

Benefits

Hands-on experience

Mentorship opportunities

Values-driven culture

Qualifications

• Relevant experience in the pharmaceutical industry required.
• Minimum qualifications include project management and coordination.

Responsibilities

• Manage process-related tasks in Veeva RIMS projects.
• Facilitate workshops and work with Regulatory SMEs.
• Maintain comprehensive documentation of processes.
• Collaborate with Change Management teams for training.

Skills

Project Management

Stakeholder Engagement

Change Management

Time Management

Education

Bachelor’s degree in Pharmacy, Medicine, or related Life Science discipline

Tools

Veeva RIMS

Job description

With us, you’ll learn fast, work smart, and make a difference. You'll build a career that matters.

Job Description - SM-Regulatory Affairs (LIF022599)

SM-Regulatory Affairs - LIF022599

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 AI Gigafactory, 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 agentic AI, 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.

Inviting applications for the role of Senior Manager - Regulatory Affairs

Responsibilities

1. Project Management & Coordination
   • Manage all process‑related tasks in Veeva RIMS projects, including planning, tracking, and reporting.
   • Ensure timely delivery of process deliverables by coordinating across cross‑functional teams and stakeholders.
2. Stakeholder Engagement
   • Facilitate workshops and working sessions with Regulatory SMEs, Affiliates, and other business units to gather input and validate process designs.
   • Act as a central point of contact for process‑related discussions and decisions.
3. Governance & Alignment
   • Ensure process designs are aligned with regulatory requirements, internal governance standards, and Veeva RIMS configuration constraints.
   • Support the development and enforcement of data governance frameworks within the regulatory domain.
   • Support decision‑making and escalation processes related to business process changes.
4. Documentation & Communication
   • Maintain comprehensive documentation of current‑state and future‑state processes, including process maps, SOPs, and decision logs.
   • Communicate process changes and impacts effectively to all relevant stakeholders.
5. Change Management Support & Training
   • Collaborate with Change Management teams to support training, communication, and adoption of redesigned processes.
   • Monitor and address user feedback during process rollout and stabilization phases.
6. Migration Strategy & Planning
   • Define migration scope, timelines, resources, and success metrics.
   • Develop detailed migration plans and risk mitigation strategies.
   • Manage migration activities across multiple workstreams and ensure compliance with GxP, 21 CFR Part 11, and validation protocols (IQ, OQ, PQ).
7. Support Data Migration Activities
   • Collaborate with IT and business teams to support data extraction, transformation, and loading (ETL) processes into Veeva RIMS.
   • Validate migrated data to ensure accuracy, completeness, and compliance with business and regulatory requirements.
8. Data Mapping & Transformation
   • Lead mapping of legacy data structures to Veeva Vault RIM.
   • Oversee ETL (Extract, Transform, Load) processes ensuring accuracy and completeness.
9. System Configuration & Governance
   • Support configuration of Veeva Vault RIM modules.
   • Establish governance frameworks for data quality, access control, and audit readiness.
10. Testing & Validation
    • Lead testing to validate migrated data and system functionality.
    • Document validation results and support regulatory audits.
11. Continuous Improvement & Reporting
    • Track regulatory updates and adapt processes accordingly.
    • Drive automation and digital transformation initiatives for regulatory data management.
12. Data Quality & Standardization
    • Oversee data mapping, cleansing, and enrichment for IDMP and XEVMPD.
    • Ensure controlled terminology alignment across regulatory systems.

Qualifications we seek in you!

• • Bachelor’s degree, preferably in Pharmacy, Medicine, Chemistry, or related Life Science discipline. Relevant experience in the pharmaceutical industry required.
• Minimum qualifications: [details omitted for brevity – content retained from source]

Preferred Qualifications / Skills

• Enthusiasm & confidence
• Adhere to our principles and values
• Time Management skills

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.