GSK Regulatory Affairs Graduate Internship 2021

Graduate Job Purpose:

This position has responsibility for Regulatory Affairs in defined portfolios or activity streams within their markets. This includes:

• Product Life Cycle Management (Variations)
• OSA Dossier Management Tasks
• OSA Administrative

What will you do?

• Document Management System
• Ensure there is:
• Product History for each product
• Submission Management (Dates) (Pre-Reg & Post Reg)
• Approvals Management (Dates) (Pre-Reg & Post Reg)
• Ensuring there is an electronic dossier for each product that matches the hard copy
• Dossier Management
• Receipt and tracking of all correspondence received from Medicine Regulatory Authorities (MRAs) for OSA
• Updating and maintaining of trackers and databases with the current information
• Filing of Correspondence received from OSA Medicine Regulatory Authorities (electronically and hard copy)
• Filing of Registration certificates received from OSA Medicine Regulatory Authorities
• Tracking and processing of retention fees in OSA
• Dossier Room Management: Tasks
• Superseding and Auditing of OSA dossiers, ensure there is electronic and hard copy file
• Documenting amendments for submission to OSA MRA on relevant trackers
• Assist internal customers with product dossier information as required
• Administrative Tasks:
• Assist the OSA RA Manager with projects as may be assigned from time to time
• Controlling and maintaining the submission tracking log for OSA
• Typing, copying, scanning, tabbing and binding documents for submission as required
• Handling receipt of correspondence from OSA MRA and filing (electronically and hard copy)
• Management of all filing, copying and preparation of new product submissions and variations under the direct supervision of the OSA Regulatory Affairs Manager
•  Management of events, variations and approvals for OSA
• Understands and abides by GSK policies and procedures, conducts Management Monitoring
• Individual Performer:  Uses our values and expectations to drive actions and decisions, role models values and expectations

You’ll be excited by the thought of:

• working in a multicultural environment
• inspiring a team to achieve unprecedented success
• joining an international community of like-minded graduates who, alongside their day jobs, help shape and run the Graduate programme

You’ll need:

• Bachelor’s Degree in business related field
• Computer Literate in Excel, PowerPoint, Word, Outlook
• Strong interpersonal skills – the ability to connect people and ideas to deliver value to the business
• The ability to work in a dynamic, fast paced environment
• A strong interest in a career in the healthcare industry
• Written and spoken fluency in English