Regulatory Affairs Job at Genpact | Life Sciences Candidates, Apply Now
Ready to lead in the age of AI and digital innovation? Genpact is inviting applications for a Lead Associate – Regulatory Affairs Operations Global (Junior Publisher) focused on the US market. This high-demand regulatory affairs job requires knowledge of ICH/FDA guidelines and eCTD structure. Join the Genpact career track and leverage your expertise in technical publishing to accelerate regulatory success for global enterprises in this vital life sciences job.
- Designation: Lead Associate – Regulatory Affairs Operations Global – Junior Publisher
- Location: India – Mumbai
About The Company
Genpact (NYSE: G) is an advanced technology services and solutions company that delivers lasting value for leading enterprises globally. We are leading the charge in redefining industries through AI and digital innovation, exemplified by our industry-first AI Gigafactory accelerator. Powered by curiosity, courage, and innovation, our teams implement data, technology, and AI to create tomorrow, today. When you join Genpact, you join 140,000+ bold thinkers committed to accelerating your Genpact career and fueling progress globally.
Key Responsibilities
The role demands a publisher with demonstrated ability to execute responsibilities in a highly regulated environment, making it a crucial regulatory affairs job in the
life sciences job sector.- eCTD Publishing: Lead the publishing and technical validation of eCTD for US submissions.
- Quality Review: Perform final technical quality review and ensure alignment with CTD structure.
- Dispatch: Dispatch submissions (eCTD/CTD/NeeS/Paper) to the relevant authority or affiliate.
- Post-Submission: Perform post-submission processing, including receiving acknowledgements and capturing electronic receipts and metadata in the RIM (Regulatory Information Management) system.
- Correspondence Management: Capture and upload submissions-related correspondence (documentation, commitments) from health authorities.
- Compliance: Ensure all activities adhere to Genpact’s principles and values.
Essential Qualifications and Expertise
Success in this regulatory affairs job requires a specific technical and regulatory foundation:
Minimum Qualifications
- Education: Bachelor’s degree, preferably in a Life science discipline, required with relevant experience in the pharmaceutical industry.
- Regulatory Knowledge (Mandatory): In-depth knowledge of ICH guidelines and the FDA guidelines for the US market.
- Publishing Systems: Working knowledge of eCTD/CTD/NeeS types of submission and industry standard publishing systems (e.g., Liquent, DocuBridge).
- Language: Advanced level in the English language (written and verbal).
Preferred Qualifications/ Skills
- Enthusiasm & confidence.
- Effective time management and organizational skills.
- Flexibility to adapt to a changing environment.
This regulatory affairs job offers a fast-track Genpact career focused on technical publishing excellence in the pharmaceutical field. If you possess mandatory ICH and FDA knowledge and seek a high-impact life sciences job in Mumbai, don’t miss this opportunity to join Genpact and build tomorrow together. Apply before the deadline of December 20, 2025.
