Roles & Responsibilities
• Perform publishing and technical validation of regulatory submissions (eCTD/CTD/NEES/Paper) for the US market
• Conduct final technical quality review of submission dossiers
• Dispatch submissions to health authorities or affiliates as per regulatory timelines
• Handle post-submission activities including acknowledgements, receipts, and metadata capture in RIM systems
• Upload and manage health authority correspondence, commitments, and related documentation
• Ensure compliance with ICH and FDA guidelines in a regulated, process-driven environment
• Coordinate with internal stakeholders and ensure timely communication of submission status
Qualification
• Bachelor’s degree in Pharmacy, Medicine, Chemistry, or related Life Sciences discipline
Experience
• Relevant experience in Regulatory Affairs Operations / Regulatory Publishing within the pharmaceutical industry
Skills
• Strong knowledge of ICH and FDA guidelines (US market)
• Hands-on experience with eCTD, CTD, NEES, and paper submissions
• Expertise in publishing tools such as Liquent, DocuBridge, or similar systems
• Advanced English communication skills
• Good understanding of RIM systems and regulatory workflows
• Time management, organizational, and multitasking skills
• Attention to detail and quality-focused mindset
• Flexibility to adapt in a fast-changing environment
About the Organisation
Genpact is a global advanced technology services and solutions company that helps leading enterprises drive digital transformation through data, technology, and AI. Known for its strong regulatory, life sciences, and operations expertise, Genpact supports global pharma companies with end-to-end regulatory and compliance solutions while fostering innovation and continuous growth.
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