Job Title: Lead Associate – Regulatory Affairs (US Market Publishing)
Location: Mumbai, Maharashtra, India
Company: Genpact
Employment Type: Full-Time
Experience Required: 3–6 years of experience in Regulatory Affairs publishing within the pharmaceutical or life sciences industry
About Genpact
Genpact (NYSE: G) is a global professional services firm delivering advanced technology solutions and digital transformation services to leading enterprises worldwide. The company combines deep industry expertise with innovative technologies such as artificial intelligence, data analytics, and automation to help organizations operate more efficiently and scale growth.
Through initiatives such as the AI Gigafactory, Genpact is pioneering advanced AI-driven solutions that address complex enterprise challenges. With a workforce of over 140,000 professionals globally, the organization empowers businesses across industries to transform operations, accelerate innovation, and remain competitive in rapidly evolving markets.
Role Overview
Genpact is seeking a Lead Associate – Regulatory Affairs to support publishing activities for regulatory submissions in the United States pharmaceutical market. The role involves managing electronic regulatory submissions, ensuring compliance with ICH and FDA regulatory standards, and coordinating submission processes within highly regulated environments.
The successful candidate will play a key role in preparing and validating electronic Common Technical Document (eCTD) submissions, managing regulatory documentation, and supporting regulatory operations teams throughout the submission lifecycle.
Key Responsibilities
Regulatory Submission Publishing
Prepare and publish electronic regulatory submissions in eCTD format for the United States market.
Ensure submissions comply with International Council for Harmonisation (ICH) guidelines and US FDA regulatory requirements.
Perform technical validation of regulatory submission packages before final dispatch.
Technical Review and Quality Assurance
Conduct final technical quality reviews to ensure submission readiness and compliance with regulatory standards.
Identify and resolve publishing issues related to file structures, hyperlinks, bookmarks, and document formatting.
Ensure accuracy and completeness of regulatory submission documentation.
Submission Dispatch and Regulatory Communication
Dispatch regulatory submissions in eCTD, CTD, NeeS, or paper formats to relevant regulatory authorities or regional affiliates.
Coordinate submission timelines and ensure successful delivery to regulatory agencies.
Manage post-submission activities including acknowledgement tracking and regulatory receipt documentation.
Regulatory Information Management
Capture and maintain submission-related metadata within Regulatory Information Management (RIM) systems.
Upload regulatory correspondence, commitments, and documentation received from health authorities.
Maintain accurate records of regulatory submission history and associated documentation.
Operational Collaboration
Collaborate with regulatory affairs teams, medical writing teams, and project stakeholders to ensure timely submission preparation.
Support regulatory operations in managing submission timelines and regulatory compliance requirements.
Educational Qualifications
Bachelor’s degree in Pharmacy, Medicine, Chemistry, Life Sciences, or a related scientific discipline.
Required Skills and Expertise
Strong knowledge of International Council for Harmonisation (ICH) guidelines and US FDA regulatory requirements.
Hands-on experience with regulatory submission formats including eCTD, CTD, NeeS, and paper submissions.
Proficiency in industry-standard regulatory publishing tools such as Liquent, DocuBridge, or similar platforms.
Understanding of regulatory information management systems and electronic submission processes.
Strong attention to detail and ability to work within highly regulated environments.
Professional Competencies
Excellent written and verbal communication skills in English.
Strong time management and organizational skills.
Ability to work effectively in fast-paced, process-driven regulatory environments.
Flexibility and adaptability to evolving regulatory requirements and operational processes.
Strong analytical and problem-solving capabilities.
Career Opportunities at Genpact
Working at Genpact provides professionals with opportunities to contribute to global transformation initiatives driven by digital innovation and advanced technologies. Employees gain access to continuous learning, mentorship programs, and exposure to global enterprise projects across industries.
Genpact fosters a collaborative and inclusive culture where innovation, integrity, and customer-focused solutions drive organizational success.
Equal Opportunity Employer
Genpact is committed to creating an inclusive workplace and provides equal employment opportunities to all applicants regardless of race, color, religion, gender, age, nationality, disability, veteran status, sexual orientation, gender identity, or any other protected characteristic under applicable law. The company maintains a work environment built on respect, integrity, innovation, and collaboration.
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