Job Title: Management Trainee, Regulatory Affairs
Location: Mumbai, India
Company: Genpact (NYSE: G)
Job Posting Date: Dec 27, 2024
Job Unposting Date: Jan 26, 2025
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 driven by curiosity, entrepreneurial agility, and a desire to create lasting value for clients. We serve leading enterprises, including Fortune Global 500 companies, using our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI.
The Management Trainee, Regulatory Affairs program is designed to support clients with regulatory submissions that impact registrations of small molecules, biologics, and combination products. You will work with the Global Regulatory Affairs (GRA) team to ensure compliance with global regulatory requirements and contribute to the strategic direction of assigned medicinal products.
Global Regulatory Oversight:
Maintain global regulatory oversight of assigned established products.
Cross-Functional Team Representation:
Represent GRA in product-specific cross-functional teams.
Regulatory Strategy:
Establish global regulatory strategies to ensure products remain on the market globally.
Regulatory Guidance:
Provide regulatory guidance for worldwide maintenance activities for assigned products, including Line Extensions, Renewals, Variations, PSURs, Risk Management Plans, and more.
Document Preparation:
Provide global strategic regulatory guidance and input to key regulatory documents (e.g., CTD Modules 2, 4, 5, and selected Module 1 parts) according to international standards.
Knowledge Management:
Maintain up-to-date knowledge of global regulatory requirements and evolving regulatory trends.
Lifecycle Submissions:
Manage lifecycle submissions, including Variations, PSURs/PBRERs.
Document Collection and Dispatch:
Collect document requirements and finalize cover letters, prepare content plans, and dispatch packages to local country representatives or Health Authorities (HAs).
Audit and Inspection Support:
Support and coordinate audit and inspection-related activities.
Client Process Adherence:
Act in accordance with client processes and systems.
Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, religion, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, disability, or any other characteristic protected by applicable laws.
To apply, visit [Genpact Careers Page] or apply directly through the job posting link.
This job description provides an overview of the role and responsibilities, highlighting qualifications and opportunities for professional growth at Genpact. Let me know if you need further adjustments!
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