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 quick-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 Regulatory Affairs Operations

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

Shift- US

Have valuable knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, DocuBridge, etc.

Responsibilities

- Research and stay updated on regulations relevant to the industry. Provide guidance and training to staff on compliance matters.
- Monitor and report on compliance issues to management.
- Hands on experience with Medical device UDI data aggregation,



country specific UDI requirements guidelines/Global UDI Regulations, labels, medical device UDI attributes and terminology, Implementation Global UDI data clean up strategy..
- Knowledge of the European Medical Device Regulation (EU MDR), EUDAMED, FDA GUDID, Understanding of Technical file content.
- Understanding on labelling artwork, labels
- Prior experience in PIM system, SAP, Master control, RIM, Regulatory tool and Processes is desired.
- Advance data Analysis skills, advance excel, data analysis, data science.

Qualifications we seek in you!

• Bachelor’s degree, preferably in Pharmacy, Medicine, Chemistry, or related Life science discipline required with relevant experience in the pharmaceutical industry.
• Mandatory Knowledge of ICH and FDA guideline for US market.
• Working knowledge of eCTD/ CTD/NEES types of submission, industry standard publishing systems.
• Should be advance level in English language.
• In depth working knowledge of eCTD/CTD/NEES/Paper types of submission, industry standard publishing systems.
• Effective time management and organizational skills.
• Effective communication.
• Flexibility to adapt to a changing environment.

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 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 agile 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.

📌 Specialist - Regulatory Affairs - Operations (Bengaluru)
🏢 Genpact
📍 Bengaluru