SM-Regulatory Affairs

Ready to shape the future of work

At Genpact we dont just adapt to changewe drive it. 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 tech-driven environment love solving real-world problems and want to be part of a team thats 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 LinkedIn X YouTube and Facebook.

Inviting applications for the role of Senior Manager -Regulatory Affairs

Responsibilities

Management & Coordination

all process-related tasks in Veeva RIMS projects including planning tracking and reporting.

timely delivery of process deliverables by coordinating across cross-functional teams and stakeholders.

Engagement

workshops and working sessions with Regulatory SMEs Affiliates and other business units to gather input and validate process designs.

as a central point of contact for process-related discussions and decisions.

& Alignment

process designs are aligned with regulatory requirements internal governance standards and Veeva RIMS configuration constraints.

the development and enforcement of data governance frameworks within the regulatory domain.

decision-making and escalation processes related to business process changes.

& Communication

comprehensive documentation of current-state and future-state processes including process maps SOPs and decision logs.

process changes and impacts effectively to all relevant stakeholders.

Management Support & Training

with Change Management teams to support training communication and adoption of redesigned processes.

and address user feedback during process rollout and stabilization phases.

Strategy & Planning

migration scope timelines resources and success metrics.

detailed migration plans and risk mitigation strategies.

migration activities across multiple workstreams and ensure compliance with GxP 21 CFR Part 11 and validation protocols (IQ OQ PQ).

Data Migration Activities

with IT and business teams to support data extraction transformation and loading (ETL) processes into Veeva RIMS.

migrated data to ensure accuracy completeness and compliance with business and regulatory requirements.

Mapping & Transformation

mapping of legacy data structures to Veeva Vault RIM.

ETL (Extract Transform Load) processes ensuring accuracy and completeness.

Configuration & Governance

configuration of Veeva Vault RIM modules.

governance frameworks for data quality access control and audit readiness.

& Validation

testing to validate migrated data and system functionality.

validation results and support regulatory audits.

Improvement & Reporting

regulatory updates and adapt processes accordingly.

automation and digital transformation initiatives for regulatory data management.

Quality & Standardization

data mapping cleansing and enrichment for IDMP and XEVMPD.

controlled terminology alignment across regulatory systems.

Qualifications we seek in you!

Bachelors degree preferably in Pharmacy Medicine Chemistry or related Life science discipline required with relevant experience in the pharmaceutical industry.

Minimum Qualifications

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 140000 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.

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.

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full-Time

Experience : years

Vacancy : 1