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Technical Associate -Regulatory Affairs @ Genpact

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 Technical Associate -Regulatory Affairs

Job Description

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 genpact.com and on LinkedIn, X, YouTube, and Facebook.

Inviting applications for the role of Technical Associate, Regulatory Affairs


**Work Location**: Mumbai(Work from office)


This role directly contributes to the Companys revenue growth and margin by leading operational teams in Regulatory Space. Specifically, the Technical Associate is required to:


Responsibilities

  • Define and maintain data governance standards, including data definitions and naming conventions.
  • Ensure data quality, consistency, and regulatory compliance across Veeva Vault RIM.
  • Define and govern controlled vocabularies (CVs) and pick lists, aligned with regulatory standards (IDMP / ISO).
  • Manage CV changes and perform OOTB gap analysis in collaboration with SMEs.
  • Identify and manage master data domains (e.g., substances, products, organizations), including data ownership, stewardship, and lifecycle rules.
  • Ensure master data consistency and alignment across Veeva Vault, integrated systems, and reporting.
  • Define governance rules for transactional data (submissions, registrations, variations) and ensure proper master data usage and linkage.
  • Support data quality checks, validations, and issue resolution across transactional records.
  • Support datarelated business admin configurations, including pick lists and reference data in Veeva Vault.
  • Collaborate with Veeva admins and IT teams for impact analysis, testing, and validation of data configurations.
  • Perform currentstate (asis) and futurestate (tobe) process analysis aligned with Veeva Vault RIM capabilities.
  • Define and document endtoend business processes, including data touchpoints, dependencies, ownership, and governance controls.
  • Work closely with business SMEs, regulatory teams, IT, and Veeva partners to ensure alignment.
  • Facilitate workshops for data definition, CV alignment, and process harmonization, acting as a bridge between business and technical teams.

Qualifications we seek in you!

Minimum Qualifications

  • Pharmaceutics and Chemistry background is preferred with good years of experience
  • Strong understanding of Veeva Vault RIM (data model, admin concepts).
  • Experience with data governance, master data, and CV management.
  • Exposure to IDMP and regulatory data standards (preferred).
  • Experience in process mapping and business analysis.
  • Strong communication and stakeholdermanagement 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.
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.

Job Classification

Industry: BPM / BPO
Functional Area / Department: Legal & Regulatory
Role Category: Legal & Regulatory - Other
Role: Legal & Regulatory - Other
Employement Type: Full time

Contact Details:

Company: Genpact
Location(s): Mumbai

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Keyskills:   Regulatory Affairs Drug Regulatory Affairs CTD Submission DocuBridge Pharmaceutical Ectd Document Review ICH Liquent

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