Job Description

Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose - the relentless pursuit of a world that works better for people - we serve and transform leading enterprises, including the Fortune Global 500, with our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI.We are inviting applications for the role of Management Trainee, Regulatory affairs.Introduction:
This program is intended to support client in their requested requirement for regulatory submissions that may have impact on registrations of small molecules, biologics and combination products.Responsibilities:

• Maintain global regulatory oversight of assigned established products
• Representation of Global Regulatory Affairs (GRA) in product-specific cross functional teams
• Establish global regulatory strategies that ensure keeping the assigned established products on the market globally
• Provision of regulatory guidance and operational excellence for worldwide regulatory maintenance activities for assigned medicinal products, including but not limited to , Line Extensions, Renewals, Variations, Periodic Safety Reports (e.g. PSUR), Risk Management Plans, Direct Healthcare Professional Communication, HA Requests, HA Interactions (e.g. Scientific Advice), Referrals, Production Transfers, Marketing Authorization Transfers or Withdrawals, Marketing Authorization Applications in the context of late geographical expansion, Post-marketing Clinical Trial Activities, etc.
• Provision of 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 regulatory standards as well as Client processes.
• Maintain up-to-date knowledge and oversight of global regulatory requirements, guidelines, evolving regulatory trends and developments as well as monitoring of relevant product-specific competitor information
• Management of lifecycle submissions (Variations, PSURs/PBRERs according to the products)
• Prepare content plan and Finalise cover letter
• Collection of document requirements according to the request and timelines
• Dispatch package to Local country representatives or HA and archival of package in archival system
• Request of registration samples
• Coordination and preparation of supportive documents (general statements, CPPs etc.) including legalization of documents
• Support and coordination of audit and inspection related activities
• Acting and living in client processes, and systems

Qualification: At least Bachelor's degree required in for Pharmaceutical: science, engineering, or related field (advanced degree preferred).
Genpact is an Equal Opportunity Employer and considers applicants for all positions 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 or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. Get to know us at genpact.com and on LinkedIn, X, YouTube, and Facebook.
Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a 'starter kit,' paying to apply, or purchasing equipment or training.

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