Manager - Regulatory Affairs
Ready to turn bold ideas into real-world impact?
At Genpact, we don’t just adapt to change, we lead it. AI and digital innovation are transforming the way businesses work, and we’re at the forefront of it. Genpact’s AI Gigafactory, our industry-first accelerator, exemplifies how we scale advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. Whether tackling complex challenges through large-scale models or agentic AI, our breakthrough solutions tackle companies’ most complex challenges.
If you thrive in a fast-moving, innovation-driven environment, love building and deploying cutting-edge AI solutions, and want to push the boundaries of what’s possible, this is your moment.
Genpact (NYSE: G) is an agentic and advanced technology solutions company. We leverage process intelligence and artificial intelligence to deliver measurable outcomes. With a strong partner ecosystem and decades of client trust, we provide innovative solutions that transform how businesses run. Powered by a team with an active learning mindset and client centricity at its core, we deliver lasting value for the world’s leading enterprises.
Get to know us at genpact.com and on LinkedIn, YouTube, X, and Facebook.
Job Description
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Maintain RA data governance frameworks, including roles for data owners and stewards
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Maintain and update data governance documentation, data catalogue entries, and controlled vocabularies.
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Execute codification of rules in Data Quality tools and monitor adherence.
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Support centralized master and reference data management (MDM/RDM) processes.
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Oversee tickets and workflows for reference and master data changes (organization, substance, medicinal product). Service Now (SNOW)
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Support harmonization of Regulatory reference and Master data models with enterprise standards (e.g., medicinal product, device, packaging hierarchies).
- Support IDMP-based modelling and alignment of data between RIM and Master Data management system
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Participate in medicinal product governance meetings and expert community sessions.
- Support enterprise-level modelling principles (conceptual, logical, physical) and metadata management against internal and external benchmarks
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Perform routine data quality checks and generate metrics reports.
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Coordinate with Data Stewards and functional Data Owners to resolve data quality issues.
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Track and report on KPIs related to accuracy, consistency, and completeness.
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Act as operational liaison for RA Data Governance activities with internal teams.
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Support communication and training sessions on data governance processes and systems.
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Provide operational input and resources for projects impacting RA data governance.
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Assist in configuration and testing of data governance tools
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Manage Jira boards for RA data initiatives, including backlog prioritization, epics, and user stories. Ensure traceability of requirements and validation results in Jira for compliance. Monitor backlog and escalate issues as necessary.
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Support running and reporting on KPI’s
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Analyse data quality trends, monitoring progress and report findings to leadership
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Prepare compliance reports for regulatory requirements (e.g., IDMP, XEVMPD)
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Automate routine reporting tasks to improve efficiency
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Translate analytics into actionable insights for stakeholders
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Benchmark internal metrics against industry standards
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Gather feedback from users to continuously improve reporting tools and outputs
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Bachelor’s degree in life sciences, data science, or related field.
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Good experience in data governance, data quality, or regulatory data management
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Strong communication, business writing, and project management skills.
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Experience with data management in pharmaceutical regulatory affairs.
- Experience facilitating meetings with cross-functional teams
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Familiarity with regulatory requirements, structured data submissions, and compliance practices, including XEVMPD & IDMP
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Familiarity with data management and data quality/governance tools like Reltio, Collibra and Ataccama
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Familiarity with Veeva RIM, Service Now, Jira and SAP appreciated
Qualifications
Bachelors - Health Administration, Bachelors - Healthcare, Bachelors - Pharmacy, Masters - Public Health, Masters - Regulatory Affairs
Certifications
Certified Compliance Officer (CCO) - VskillsVskills, Certified Information Privacy Manager (CIPM) - International Association of Privacy Professionals (IAPP)International Association of Privacy Professionals (IAPP), Certified Regulatory and Compliance Professional (CRCP) - JSS UniversityJSS University, Certified Regulatory Compliance Manager (CRCM) - The International Association of Risk and Compliance Professionals (IARCP)The International Association of Risk and Compliance Professionals (IARCP), Certified Risk Professional (CRP) - UdemyUdemy
Required Skills
Audit Analytics, Change Management, Compliance Risk Management, Data Governance, Life Science, Regulatory Affair Management, Risk Management
Language
English (Required)
Language Proficiency -
Proficient - C2
Additional Job Location -
Job Type
Regular
Master Skill List -
Regulatory Affairs - Practice
Remote Type -
Office
Work Shift -
Flex Time (India)
Why join Genpact?
- Lead AI-powered transformation – Drive innovation and solve real-world business challenges that matter
- Make an impact – Help global enterprises solve business challenges that matter
- Accelerate your career – Gain hands-on experience, mentorship, and world-class learning opportunities to stay ahead
- 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 140,000+ coders, 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.
