Specialist - Regulatory Affairs - Operations 4B

Genpact; Mumbai; Hybrid; INR 1,000,000 - 1,800,000; Full time

Job summary

Genpact in India is seeking a Specialist - Regulatory Affairs - Operations to maintain and update regulatory data within multiple systems, ensuring accuracy and compliance. You will support submissions, variances, renewals, and registrations while collaborating with Regulatory Affairs, Clinical, Quality, Manufacturing, and IT teams to align data standards and processes.

You will develop data quality controls, generate regulatory reports and dashboards for stakeholders, and contribute to

Qualifications

• Bachelors - Health Administration
• Bachelors - Healthcare
• Bachelors - Pharmacy
• Masters - Public Health
• Masters - Regulatory Affairs Certifications Certified Compliance Officer (CCO) - VskillsVskills
• Certified Public Accountant (CPA) - Perfekt SzolnokPerfekt Szolnok
• Certified Regulatory and Compliance Professional (CRCP) - JSS UniversityJSS University
• Certified Regulatory Compliance Manager (CRCM) - The International Association of Risk and Compliance Professionals (IARCP)

Responsibilities

• Maintain and update regulatory data in company databases and regulatory information management systems (RIMS).
• Ensure accuracy, completeness, consistency, and compliance of regulatory data.
• Support preparation and tracking of regulatory submissions, approvals, renewals, variations, and registrations.
• Perform data quality reviews and reconciliation activities across multiple systems.
• Collaborate with Regulatory Affairs, Clinical, Quality, Manufacturing, and IT teams to ensure alignment of regulatory data.
• Develop and maintain regulatory data standards, workflows, and documentation.
• Generate regulatory reports, metrics, and dashboards for stakeholders.
• Support inspections, audits, and regulatory compliance activities.
• Identify opportunities for process improvements and automation.
• Provide user support and training related to regulatory data systems and processes.

Skills

Regulatory Affairs

English (C2)

Veeva

Indian Hybrid

Education

Bachelors - Health Administration

Bachelors - Healthcare

Bachelors - Pharmacy

Masters - Public Health

Masters - Regulatory Affairs Certifications Certified Compliance Officer (CCO) - Vskills

Certified Public Accountant (CPA) - Perfekt Szolnok

Certified Regulatory and Compliance Professional (CRCP) - JSS University

Certified Regulatory Compliance Manager (CRCM) - IARCP

Job description

Specialist - Regulatory Affairs - Operations

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.

Responsibilities

• Maintain and update regulatory data in company databases and regulatory information management systems (RIMS).
• Ensure accuracy, completeness, consistency, and compliance of regulatory data.
• Support preparation and tracking of regulatory submissions, approvals, renewals, variations, and registrations.
• Perform data quality reviews and reconciliation activities across multiple systems.
• Collaborate with Regulatory Affairs, Clinical, Quality, Manufacturing, and IT teams to ensure alignment of regulatory data.
• Develop and maintain regulatory data standards, workflows, and documentation.
• Generate regulatory reports, metrics, and dashboards for stakeholders.
• Support inspections, audits, and regulatory compliance activities.
• Identify opportunities for process improvements and automation.
• Provide user support and training related to regulatory data systems and processes.

Qualifications

• Bachelors - Health Administration
• Bachelors - Healthcare
• Bachelors - Pharmacy
• Masters - Public Health
• Masters - Regulatory Affairs Certifications Certified Compliance Officer (CCO) - VskillsVskills
• Certified Public Accountant (CPA) - Perfekt SzolnokPerfekt Szolnok
• 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)

Required Skills

• Veeva Language English (Required)
• Language Proficiency - Proficient - C2
• Job Type: Regular
• Remote Type: Hybrid
• Shift: Day Job (India)
• Master Skill List: Regulatory Affairs - Operations
• Additional Job Location

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

Job Information

• Job Location: India
• Job Type: Regular
• Remote Type: Hybrid
• Shift: Day

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 or 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.

We’re an agentic and advanced technology solutions company that runs mission‑critical operations for the world’s leading companies, while building and deploying the agentic products and technology that power those operations. Our teams bring deep expertise to shape what AI can do and change how businesses actually run. Join us to build the career you want — and be on it because you’ll be in it. At Genpact, your expertise grows because you’re inside the work. Whether you build AI systems or bring deep knowledge of how businesses run, you’ll work on real challenges that change how the world's leading companies operate. There’s a lot to learn here, and room to grow.