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Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. With over 125,000+ employees across 30+ countries, we are powered by our purpose – the relentless pursuit of a world that works better for people. At Genpact, we transform enterprises, including Fortune Global 500 companies, with deep industry knowledge, digital operations expertise, and advanced technology.
Job Title
Management Trainee – Regulatory Affairs
Job Location
India – Mumbai
Job Type
Full-time
Key Dates
- Job Posting Date: December 27, 2024
- Application Deadline: January 26, 2025
Qualifications and Skills Required
Education
- Bachelor’s degree in Pharmaceutical Sciences, Engineering, or related fields (advanced degrees preferred).
Experience
- Freshers are welcome.
- Prior exposure to regulatory affairs is advantageous.
Key Skills
- Strong communication skills.
- Excellent analytical abilities.
- Attention to detail.
Job Responsibilities
Primary Duties
- Maintain global regulatory oversight of assigned products.
- Represent Global Regulatory Affairs (GRA) in cross-functional teams.
- Develop and establish global regulatory strategies to ensure product compliance globally.
Key Activities
- Handle lifecycle submissions: Variations, PSURs/PBRERs.
- Prepare and finalize documentation, including cover letters and content plans.
- Dispatch regulatory packages to local representatives or Health Authorities (HAs).
- Coordinate supportive documents such as legalization of documents and general statements.
- Ensure compliance with evolving global regulatory requirements and trends.
Additional Responsibilities
- Provide global strategic input for regulatory documents (e.g., CTD Modules 2, 4, 5).
- Support post-marketing clinical trial activities and lifecycle management.
- Coordinate registration samples and audit/inspection activities.
- Actively work within client systems and processes.
Role Highlights
| Attribute | Details |
|---|---|
| Job Title | Management Trainee – Regulatory Affairs |
| Primary Location | Mumbai, India |
| Education Level | Bachelor’s / Graduation / Equivalent |
| Schedule | Full-time |
| Eligibility | Freshers and experienced professionals |
About Genpact
Genpact is committed to diversity, equity, and inclusion in the workplace. We value respect, innovation, and a customer-centric approach.
Why Join Genpact?
- Work with a global leader in professional services.
- Contribute to transformative projects with Fortune Global 500 companies.
- Access to learning and growth opportunities in a dynamic environment.
How to Apply
- APPLY HERE: Click Here
Equal Opportunity Statement
Genpact is an Equal Opportunity Employer. We consider applicants without regard to:
- Race
- Color
- Religion or belief
- Sex
- Age
- National origin
- Citizenship status
- Marital status
- Military/veteran status
- Genetic information
- Sexual orientation
- Gender identity
- Physical or mental disability
Fraud Alert
Genpact does not charge any fees during the hiring process. Beware of scams that ask for payments, such as purchasing starter kits or training equipment.
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