Lead Associate – Regulatory Affairs Operations
Job Code: LIF022775
Location: Mumbai, India
Employment Type: Full-Time
Industry: Regulatory Affairs | Pharmaceutical Operations | Life Sciences
Experience Required: 4–7 Years
Education: Bachelor’s Degree (Pharmacy/Life Sciences preferred)
Posted On: 10 December 2025
Application Deadline: 9 January 2026
About Genpact
Genpact (NYSE: G) is a global advanced technology services and solutions company driving meaningful transformation for leading enterprises worldwide. With deep domain expertise, operational excellence, and strong capabilities in data, AI, and digital innovation, Genpact enables organizations to work smarter, scale faster, and stay ahead in a rapidly evolving business landscape.
At Genpact, innovation is powered by curiosity, courage, and collaboration. Through initiatives such as the AI Gigafactory, Genpact is redefining how global enterprises leverage technology to solve complex regulatory, operational, and business challenges.
Role Overview
Genpact is hiring a Lead Associate – Regulatory Affairs Operations to support global regulatory publishing and submission activities. This role is ideal for professionals with strong expertise in ICH guidelines, eCTD/CTD submissions, and regulatory publishing systems, particularly for the US market. The position requires working in a highly regulated, process-driven pharmaceutical environment.
Key Responsibilities
Perform eCTD publishing and technical validation for US regulatory submissions
Conduct final technical quality checks to ensure submission readiness
Dispatch regulatory submissions (eCTD/CTD/NEES/Paper) to health authorities or affiliates
Manage post-submission activities, including acknowledgment tracking and metadata capture in RIM systems
Upload and manage health authority correspondence, commitments, and regulatory documentation
Ensure compliance with ICH, FDA, and global regulatory guidelines
Work within structured workflows and timelines in a regulated environment
Collaborate with internal stakeholders to communicate submission status and outcomes
Required Qualifications & Experience
Bachelor’s degree in Pharmacy, Medicine, Chemistry, or Life Sciences
4–7 years of relevant experience in Regulatory Affairs Operations or Regulatory Publishing
Strong working knowledge of ICH and FDA guidelines, particularly for the US market
Hands-on experience with eCTD/CTD/NEES submission formats
Proficiency with regulatory publishing tools such as Liquent, DocuBridge, or similar systems
Advanced proficiency in written and spoken English
Preferred Skills & Competencies
In-depth understanding of global regulatory submission workflows
Strong organizational and time management skills
High attention to detail and quality orientation
Effective stakeholder communication and documentation skills
Ability to adapt to changing regulatory and operational environments
Experience working in process-driven pharmaceutical or life sciences organizations
Key Attributes
High level of professionalism, confidence, and accountability
Strong alignment with ethical principles and organizational values
Ability to work independently while contributing to team objectives
Why Join Genpact
Work at the forefront of AI-enabled regulatory and digital transformation
Gain exposure to global regulatory operations and complex submissions
Accelerate career growth through continuous learning and mentorship
Collaborate with a diverse global workforce of 140,000+ professionals
Thrive in an inclusive, integrity-driven culture that values innovation and impact
Equal Opportunity Statement
Genpact is an Equal Opportunity Employer and evaluates applicants without discrimination based on race, color, religion, gender, age, nationality, disability, veteran status, sexual orientation, or any other protected characteristic. Genpact does not charge any fees at any stage of the recruitment process.
Apply via ThePharmaDaily.com
Explore verified global opportunities in Regulatory Affairs, eCTD Publishing, and Life Sciences Operations. Stay ahead in your regulatory career with curated roles from leading pharmaceutical and healthcare organizations.
Apply now for the Lead Associate – Regulatory Affairs Operations role and advance your career with Genpact through ThePharmaDaily.com.
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