Genpact Pharmaceutical Sciences Regulatory Affairs Job, Apply Online
Management Trainee, Regulatory Affairs – LIF019412
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 clients in their requested requirements for regulatory submissions that may have an impact on registrations of small molecules, biologics, and combination products.
Responsibilities:
- Maintain global regulatory oversight of assigned established products.
- Represent 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.
- Provide 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.
- 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 regulatory standards as well as Client processes.
- Maintain up-to-date knowledge and oversight of global regulatory requirements, guidelines, evolving regulatory trends and developments, and monitoring of relevant product-specific competitor information.
- Manage lifecycle submissions (Variations, PSURs/PBRERs according to the products).
- Prepare content plan and finalize cover letter.
- Collect document requirements according to the request and timelines.
- Dispatch package to Local country representatives or HA and archive package in archival system.
- Request registration samples.
- Coordinate and prepare supportive documents (general statements, CPPs, etc.), including legalization of documents.
- Support and coordinate audit and inspection-related activities.
- Act and live by client processes and systems.
Qualification:
At least a Bachelor’s degree required in Pharmaceutical Science, Engineering, or a 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 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.
Job: Management Trainee
Primary Location: India-Mumbai
Schedule: Full-time
Education Level: Bachelor’s / Graduation / Equivalent
Job Posting: Dec 27, 2024, 4:26:50 AM
Unposting Date: Ongoing
Master Skills List: Operations
Job Category: Full Time
Link to Original Notification to apply: APPLY ONLINE HERE
Keywords: Management Trainee, Regulatory Affairs, Genpact, Professional Services, Global Solutions, Fortune Global 500, Regulatory Oversight, Pharmaceutical Science, Regulatory Strategies. Genpact Pharmaceutical Sciences Regulatory Affairs Job, Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
