Regulatory Affairs Jobs at Genpact | Chemistry Graduates Apply
Are you looking for regulatory affairs jobs that combine innovation, compliance, and global impact? Genpact is inviting applications for the role of Lead Associate – Regulatory Affairs Operations Global in Mumbai. This role is ideal for professionals with strong knowledge of ICH guidelines, eCTD publishing, and regulatory submissions who want to grow their Chemistry careers with one of the world’s leading technology-driven organizations.
About Genpact
Genpact is a global advanced technology services and solutions company helping leading enterprises transform through data, AI, and digital innovation. With deep industry expertise and operational excellence, Genpact continues to shape the future of work across industries worldwide.
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 Jobs Global
You should have experience and have good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, DocuBridge, etc.
Responsibilities
In this role, you will be responsible for:
- The Role demands 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 have 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.
Minimum Qualifications
Preferred Qualifications/ Skills
Key Attributes
- 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.
Job Details
- Job Title: Lead Associate
- Primary Location: India-Mumbai
- Schedule: Full-time
- Education Level: Bachelor’s / Graduation / Equivalent
- Job Posting: Dec 10, 2025, 2:03:50 PM
- Unposting Date: Ongoing
- Master Skills List: Operations
- Job Category: Full Time
