Genpact Recruitment 2025: Technical Associate Opening in Regulatory Affairs

Genpact, a global leader in professional services and digital transformation, is currently inviting applications for the position of Technical Associate – Regulatory Affairs. Based in Mumbai, this role is designed for experienced regulatory publishers who thrive in highly regulated, process-driven environments.

As part of the Genpact team, the successful candidate will play a critical role in ensuring that life-saving pharmaceutical products meet the stringent submission requirements of global health authorities like the US FDA and Health Canada.

Core Responsibilities & Technical Scope

The Technical Associate will be responsible for the end-to-end submission publishing lifecycle, focusing on high-quality technical validation and compliance.

Submission Publishing: Executing and overseeing eCTD (electronic Common Technical Document) publishing for major markets, including the US and Canada.
Technical Quality Review: Performing final technical validation to ensure submissions are error-free and compliant with ICH standards.
Diverse Filing Types: Managing various submission types such as NDA, ANDA, BLA, IND, DMF, MAA, and NDS. This includes safety submissions, annual reports, and protocol amendments.
Global Dispatch: Handling the secure dispatch of submissions to regulatory portals including CESP, EMA, Health Canada, and the US FDA.
Post-Submission Management: Monitoring regulatory acknowledgments, capturing metadata in Regulatory Information Management (RIM) systems, and communicating status updates to stakeholders.
Metrics & Intelligence: Reporting on submission volumes and quality metrics to support future forecasting and regulatory intelligence gathering.

Candidate Requirements

Genpact is seeking a detail-oriented professional with a strong technical grasp of regulatory software and global guidelines.

Education: Bachelor’s degree in Pharmacy (B.Pharm), Medicine, Chemistry, or a related Life Science discipline.
Guidelines: Mandatory in-depth knowledge of ICH, FDA, and EMA guidelines.
Technical Skills: Advanced proficiency in industry-standard publishing systems (eCTD/CTD/NEES) and desktop applications.
Troubleshooting: Ability to perform technical troubleshooting during the compilation of complex dossiers.
Communication: Advanced English language skills and the ability to foster strong relationships with global customers.

Job Overview

Location: Mumbai, India (Office-based/Hybrid as per company policy).
Industry: Pharmaceutical / Clinical Research / Healthcare.
Functional Area: Regulatory Affairs & Operations.
Application Deadline: January 10, 2026.

How to Apply

Interested candidates can apply online through the Genpact Careers portal. Ensure your profile highlights your experience with specific publishing tools and your history of successful global submissions.