Lead Associate Reg Affairs

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 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 Companys 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!
Bachelors 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 140000 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.