Regulatory Submissions Administrator, West London
New Posting Wednesday, 11 January 2012
£24,000-£27,000
Role:
Supports the Regulatory Operations Team in the creation of regulatory submissions in their delivery of regulatory submission components and product dossiers.
Key Activities
Scanning
CD Rom burning
Formatting, & troubleshooting source documents, including but not limited to, MS Office, MS Excel, Adobe PDF
Ensure document conformance to style guide through assigned templates
Document Management
Department Communications
Status Communication
Quality Control checks of submission ready components and submission dossiers
Contributes to preparation and compilation of Department Metrics
Preparation and dispatch of regulatory submissions
Archiving activities
Data Entry for IMR
Essential Skills & Qualifications Required
Problem Solving - Ability to identify roadblocks to task completion and effectively brings them to line managers for resolution
Autonomy
Works under general direction, seeks assistance as needed
Tracks, maintains and produces regular work products
Completes work in accordance with established procedures and practices
Works with team to support achievement of submission tasks
Knowledge
Computer Literacy, including proficiency with word processing, spreadsheet and web applications
Working in matrix environment
Working in Teams
General knowledge of procedures and activities within own work area
Ability to relate^day-to-day work to business priorities
Competency
Time Management
Presentation Skills
Timely Decision Making
Customer Focus
Attention to detail
Software Competence Required
MS Office, MS Excel, Adobe PDF, Documentum, Sharepoint
Employer: Pharmaceutical Company
Employment Type: Agency Contract Rolling
Hours: Full time
Contract Term: =12 Months
Location: West of London, UK
Plan Start Date:20th February 2012
Please do not apply if you are unable to meet this start date.
Keywords:
Registration, Regulatory Affairs, MAA, CMC, Expert Reports, Clinical Trial Applications, CTA, CPMP, Dossier, Regulatory Agency, Documentum
Assigned Consultant: Kirsty Clark on 01932 234681
Please feel free to call for a detailed Job Description or additional information
Applications are reviewed within 24hrs, applicants will only receive feedback if they are suited to the role. The role may have been remarketed; if you applied for this role previously and were unsuccessful you will not receive a response. We are unable to respond to applicants who are not EU nationals unless they include evidence of right to work in full time employment with their application. Do apply with relevant information onrequired locationor salary/day rate if you are a new candidate.