Regulatory Affairs Lead Associate Job at Genpact
Genpact is hiring dynamic and detail-oriented professionals for the role of Lead Associate – Regulatory Affairs Operations Global (Junior Publisher for US Market). This Regulatory Affairs Job opportunity is ideal for candidates looking to grow in a fast-paced, AI-driven work environment while contributing to high-impact global regulatory submissions. Join a team shaping the future of digital transformation and pharmaceutical regulatory excellence. Graduates seeking for B pharma jobs and want to build their career with Genpact Careers can apply now.
About The Job
Ready to shape the future of work? At Genpact, we don’t just adapt to change—we drive it. join for Regulatory Affairs Job role as we know AI and digital innovation are redefining industries, and we’re leading the transformation. Genpact’s AI Gigafactory is an industry-first accelerator, scaling advanced tech solutions to help global enterprises work smarter and grow faster. Genpact (NYSE: G) is a global advanced technology services and solutions organization delivering long-term value to leading enterprises. Through strong business expertise, operational excellence, and cutting-edge AI-led solutions, we help companies stay ahead. Powered by curiosity, courage, and innovation, Genpact teams use data, technology, and AI to build tomorrow, today.
We are inviting applications for Regulatory Affairs Job Role . Candidates should have knowledge of ICH guidelines, CTD structure, and expertise with publishing tools like Liquent and DocuBridge.
Job Details for Regulatory Affairs Job Role:
- Publishing and performing technical validation of eCTD submissions for the US market
- Conducting final technical quality checks
- Dispatching submissions (eCTD/CTD/NeeS/Paper) to authorities or affiliates
- Managing post-submission activities: receipt acknowledgements, metadata capture in RIM, communication with stakeholders
- Handling health authority correspondence including documentation, commitments, and metadata
About the Company
Genpact is a global leader in technology-driven transformation with 140,000+ experts. Our values—courage, curiosity, integrity, and innovation—empower employees to build impactful careers. We deliver high-value outcomes across industries through AI, automation, and digital solutions.
Educational Requirements for Regulatory Affairs Job Role:
- Bachelor’s degree in Pharmacy, Medicine, Chemistry, or related Life Sciences
- Mandatory understanding of ICH and FDA guidelines for US submissions
Key Responsibilities for Regulatory Affairs Job Role:
- End-to-end eCTD/CTD/NEES publishing
- Managing submission types across global regulatory platforms
- Ensuring compliance and accurate documentation
- Maintaining submission timelines and quality deliverables
- Supporting regulatory operations in a highly regulated environment
Skills Required for Regulatory Affairs Job Role:
- Strong knowledge of eCTD/CTD/NEES systems
- Experience with industry-standard publishing tools
- Excellent English communication skills
- Time management, prioritization, adaptability
- Effective communication, organizational and problem-solving ability
- Enthusiasm, confidence, and adherence to organizational values
How to Apply for Regulatory Affairs Job Role:
Graduates seeking for B pharma jobs and want to build their career with Genpact Careers can apply via the official Genpact careers portal before the closing date.
