Regulatory Jobs at Genpact | Chemistry Candidates | Apply Now
Are you looking for Regulatory Affairs Jobs with a global organization that is redefining the future of work through AI and digital innovation? Genpact is hiring a Lead Associate – Regulatory Affairs for its Mumbai location, offering professionals a chance to work in a highly regulated, process-driven environment while contributing to global pharmaceutical submissions. This role is ideal for candidates seeking long-term growth through Genpact Careers in regulatory operations for the US market.
About Genpact
Genpact is a global professional services firm delivering advanced technology, operations, and digital transformation solutions to leading enterprises worldwide. Known for its strong presence in AI, automation, and analytics, Genpact offers exceptional growth opportunities through Genpact Careers. With a workforce of over 140,000 professionals, Genpact continues to be a top destination for aspirants seeking Regulatory Affairs Jobs and other high-impact roles across industries.
Job Description
Lead Associate – Regulatory Affairs-LIF023076
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.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 the affiliate can dispatch to the authority.
- Performing post-submission processing activities such as receiving acknowledgement from the authority of submission receipt, capturing and the electronic receipt and metadata in RIM, and 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 a related Life science discipline, required with relevant experience in the pharmaceutical industry.
- Mandatory Knowledge of ICH and FDA guidelines for the US market.
- Working knowledge of eCTD/CTD/NEES types of submission, industry standard publishing systems.
- Should be at an advanced level in the 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.
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 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.
Job Details
- Job Role: Lead Associate
- Primary Location: India – Mumbai
- Schedule: Full-time
- Education Level: Bachelor’s / Graduation / Equivalent
- Unposting Date: Feb 22, 2026
- Job Category: Full Time
