Job Description

Ready to shape the future of work?
At Genpact, we don't just adapt to change--we drive it. AI and digital innovation are redefining industries, and we're leading the charge. Genpact's AI Gigafactory, our industry-first accelerator, is an example of how we're 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 that's 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 Lead Associate -Regulatory Affairs Operations Global
This role directly contributes to the Company's revenue growth and margin by leading operational teams in Regulatory Space. Specifically, the Lead Consultant is required to:
Responsibilities
The Role demands for a publisher with demonstrated ability to execute responsibility in a highly regulated & process driven environment, the Person will be responsible for all the activities related to.
Publishing and performing technical validation of eCTD for US submissions.
Performing final technical quality review.
Dispatching submission to the relevant authority (eCTD/CTD/NeeS/Paper) or affiliate so that affiliate can dispatch to authority.
Performing post-submission processing activities such as receiving acknowledgement from authority of submission receipt; capturing and the electronic receipt and metadata in RIM; communicating submission receipt to key stakeholders.
Capturing submissions-related correspondence from health authorities, such as uploading documentation, commitments and metadata.
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

• Experience and have good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, DocuBridge, etc.

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 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.

Skills Required