Lead Associate - Regulatory Affairs

Roles & Responsibilities:
• Publish and perform technical validation of eCTD submissions for the US market
• Execute publishing activities in a highly regulated and process-driven environment
• Perform final technical quality review prior to submission dispatch
• Dispatch submissions (eCTD/CTD/NeeS/Paper) to relevant health authorities or affiliates
• Manage post-submission activities including receipt of acknowledgements and metadata capture in RIM systems
• Upload and manage health authority correspondence, commitments, and related documentation
• Ensure compliance with ICH and US FDA regulatory guidelines
• Work extensively with publishing tools such as Liquent, DocuBridge, and other industry-standard systems
• Coordinate with cross-functional stakeholders to ensure timely and compliant submissions

Qualification:
• Bachelor’s degree in Pharmacy (B.Pharm) - Preferred
• Bachelor’s degree in Medicine, Chemistry, or other Life Sciences discipline
• Relevant experience in the pharmaceutical industry, specifically in Regulatory Publishing

Experience:
• Hands-on experience in US regulatory publishing
• In-depth working knowledge of eCTD, CTD, NeeS, and Paper submissions
• Experience with industry-standard publishing systems (Liquent, DocuBridge, etc.)
• Exposure to Regulatory Information Management (RIM) systems
• Experience working in a regulated and process-driven environment
• Strong and mandatory knowledge of ICH guidelines and US FDA regulations
• Advanced proficiency in English (written and verbal communication)

Skills:
• Strong understanding of ICH guidelines and CTD structure
• Technical expertise in electronic publishing and validation
• Effective time management and organizational skills
• Strong communication and stakeholder coordination skills
• Ability to adapt to changing regulatory and business environments
• Attention to detail and high level of accuracy
• Professional integrity and adherence to organizational values

About the Organization:
Genpact is a global advanced technology services and solutions company listed on the NYSE (G). With a strong focus on AI, automation, and digital transformation, the organization helps leading enterprises drive innovation and operational excellence. Through initiatives like its AI Gigafactory, the company accelerates scalable technology solutions, enabling businesses to transform and stay ahead in a rapidly evolving digital landscape.