Genpact, a renowned global professional services firm (NYSE: G), is inviting applications for the position of Management Trainee, Regulatory Affairs. This role offers an excellent opportunity to work in a dynamic environment that shapes the future of industries through expertise in data, technology, and AI.
Company Introduction
Genpact, with a team of over 125,000 professionals in 30+ countries, is committed to transforming leading enterprises, including Fortune Global 500 companies. Guided by a relentless pursuit of excellence, the firm is focused on creating a better world by delivering innovative solutions and sustainable outcomes for its clients.
Responsibilities in the Role
As a Management Trainee in Regulatory Affairs, you will play a pivotal role in maintaining the regulatory compliance and lifecycle management of various products. Key responsibilities include:
- Ensuring global regulatory oversight of assigned products.
- Representing Global Regulatory Affairs (GRA) in cross-functional teams.
- Developing global regulatory strategies to keep assigned products compliant worldwide.
- Managing regulatory submissions such as renewals, variations, periodic safety reports, and marketing authorizations.
- Providing strategic guidance on regulatory documents, including CTD Modules 2, 4, 5, and selected Module 1 parts.
- Keeping updated with global regulatory requirements, guidelines, and competitor activities.
- Coordinating documentation processes, including legalization and dispatch to local representatives or health authorities.
- Supporting audit and inspection-related activities.
- Ensuring adherence to client processes and systems.
Qualifications
To excel in this role, candidates should meet the following criteria:
- At least a Bachelor’s degree in pharmaceutical sciences, engineering, or a related field (advanced degrees are preferred).
- Strong understanding of regulatory requirements and submission processes.
- Excellent organizational and communication skills.
Skills Required
- Knowledge of global regulatory standards and practices.
- Attention to detail and ability to manage multiple tasks.
- Proficiency in lifecycle submissions and documentation management.
- Teamwork and cross-functional collaboration skills.
