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Stephen Burt is listed as Senior Regulatory Affairs Specialist and Regulatory Project Manager based in Broadstairs, England, United Kingdom. AeroLeads shows a matched LinkedIn profile for Stephen Burt.
Stephen Burt previously worked as Senior Regulatory Affairs Specialist at Parexel and Regulatory Project Manager at Parexel. Stephen Burt studied at The Charles Dickens School.
Mr Burt is an enthusiastic highly organized and client-driven Senior Regulatory affairs specialist & Project Manager / Leader.Currently seeking opportunities within a regulatory operations / project management role to utilize my skills, experience, and expertiseWith over 11 years’ experience in this role, whom have exceeded in learning new systems and processes allowing completion to a high standard.Experience within project management including budgeting and forecasting, client liaison and regulatory submission management, alongside mentoring fellow peers. Plus able to bring to new role(s) over 18 years’ experience of highly effective organizational & management skills within the logistics industry, ensuring delivery of consignments to tight deadlines.On a personal level, I volunteer at a local grass roots football club, catering for both girls and boys youth football, I currently coach and manage a team of under 12's facilitating in weekly training sessions and match day management.I hold and enhanced DBS and have completed the required FA learnings including first aid, safeguarding and coaching badge level of UEFA C Diploma.
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Broadstairs, England, United Kingdom
Technical lead for data entry team(s).SOP review, maintenance activities and evolving improvement strategies, ensuring observed compliance throughout.Maintain familiarity with current global regulatory submission standards.SharePoint web page development and maintenance.System trainer (instructor lead training) for new starters and cross functional colleagues.
Broadstairs, England, United Kingdom
Project Management with small clients through to major partnerships. (Project start-up, Planning, Process Development, Organizing, managing all aspects of delivery, budget management and forecasting), as well as the face for the ClientWorkstream lead for a large team of 80+ resources in Delivery of Submission Management & Publishing Works for a regulatory outsourced projects.Main focal point for cross function business units to ensure timely delivery of departmental strategies.Regional Submissions Management, coordinating with publishing and strategic partners to provide paper and electronic publishing services including document preparation, legacy conversion, scanning, rendering, bookmarking, hyperlinking, compilation, table of contents creation, volumizing, pagination, and formatting of reports and simple submissions.Legacy conversion from EU EMA centralized eCTD to UK MHRA eCTD lifecycle baseline following Brexit.
Broadstairs, England, United Kingdom
Maintain familiarity with departmental standard operating procedures and work instructions, run validation test scripts. Contribute to department best practices.Maintain familiarity with current global regulatory submission standards.Document management tasks, including file transfer, storage, tracking, and archival.Delivery of Submission Management & Publishing Works for regulatory outsourced projects.Client liaison point for queries, problem solving and solutions.
Broadstairs, England, United Kingdom
Delivery of Submission Management & Publishing Works for regulatory outsourced projects.Client liaison point for queries, problem solving and solutions.
Sandwich, England, United Kingdom
Responsible for the project management and delivery of regulatory submissions for National and MRP eCTD procedures for distribution either directly to the Worldwide Health Authorities via submission portals, such as CESP, EMA ESG, or direct to the local country offices utilizing the appropriate internal IT systems.
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Stephen Burt is listed as Senior Regulatory Affairs Specialist and Regulatory Project Manager.
Stephen Burt is based in Broadstairs, England, United Kingdom.
Stephen Burt has worked for Parexel and Pfizer.
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Stephen Burt studied at The Charles Dickens School.
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