Life Science Jobs| Genpact is Hiring a Lead Associate | Apply Now
Looking for a high-growth Life Science Job with global impact? Genpact is hiring a Lead Associate – Regulatory Affairs, offering a powerful career path for professionals who want to contribute to EU regulatory submissions, digital transformation, and advanced documentation processes. This role is designed for candidates who want to elevate their Regulatory Affairs Job expertise while building a future-ready Genpact Career.
Job Details
- Job Title: Lead Associate – Regulatory Affairs
- Location: Mumbai, India
- Employment Type: Full-time
- Job ID: LIF022776
About the Company
Genpact is a global professional services and advanced technology company focused on delivering transformation through data, digital, and AI. With more than 140,000+ employees across 30+ countries, Genpact partners with the world’s leading enterprises to reimagine operations, build intelligent workflows, and accelerate innovation. The company’s culture is built on curiosity, innovation, and continuous improvement, enabling employees to work on impactful real-world challenges across industries such as pharmaceuticals, healthcare, BFSI, consumer goods, and manufacturing. For professionals in Life Sciences and Regulatory Affairs, Genpact offers a dynamic environment to grow, contribute, and build a global career powered by technology and purpose.
Key Responsibilities
1. Primary Operational Activities
- Coordinate translation and regulatory processes for EU Product Information (PI).
- Perform anonymization and upload track-change versions in RAE domain.
- Manage REDS properties, EU language file submissions, and document transitions.
- Handle communication with EU CRAs for translations and revisions.
- Ensure timely submissions (Day +5 and Day +25 requirements).
- Create, archive, and manage non-eCTD submission documentation.
- Perform post-approval activities, status updates, and communication with stakeholders.
2. EU Regional QC Activities
- QC review of EU PI, PIL, and Annex-A documents for formatting, template alignment, and translation accuracy.
- Ensure proper implementation of changes across 24 EU language versions.
- Coordinate with CRAs for linguistic checklists and feedback.
- Maintain QC checklists and support artwork creation processes.
Educational Requirements
- Bachelor’s degree or higher in Life Sciences, or related scientific field.
- 3–6 years of experience in pharmaceutical Regulatory Affairs, especially EU submissions.
Skills
- Strong knowledge of EU regulatory submissions and frameworks
- Experience with linguistic review processes for centralized EU products
- Understanding of QRD conventions and standard terminology
- Proficiency in regulatory document management systems
- Excellent communication, coordination, and document-handling skills
- Strong attention to detail and consistency in regulatory processes
This role is a strong fit for professionals aiming to build a powerful Genpact Career in the regulatory domain. If you’re looking for a future-ready Life Science Job that combines regulatory expertise, global collaboration, and real industry impact, this is an excellent opportunity to move your career forward. Don’t miss the chance to join a company shaping the future of digital and regulatory innovation.
