Job title: Regulatory Submissions Coordinator
Job type: 12 month contract + extensions
Location: Uxbridge / Middlesex / Greater London / South East England
Salary: £25 - £30/hour
A regulatory submissions coordinator with pharmaceutical regulatory experience is required by a leading Pharmaceutical company based in Uxbridge
The ideal candidate will be responsible for overseeing the preparation of regulatory submissions for global markets, as well as ensuring the timely delivery of all dossier components
In return, a salary of £25 to £30 / hour is on offer, as well as the chance to work with an industry leading organisation
Regualtory Submission Co-ordinator
Purpose
- Co-ordinates the preparation of regulatory submissions for the Programme for Registration of Established Products (PREP) and any related RTQs for delivery to LOCs in Emerging Markets and Asia Pacific Region (EM&AP) and specific European Markets
Responsibilities and Accountabilities:
*Monitors PREP events supplied by commercial and update plans and Local operating companies
(LOC), detailing all requirements and planned dates of execution
*Checks with relevant groups (Global CMC, Global Labelling, GRA TGs) to understand any
ongoing regulatory activities that may affect the submission package, agrees and documents
strategy
*Liaises with the documentation suppliers to ensure components (dossiers, samples,
certification) will be delivered in a timely fashion
*Prepares the following data package components according to the planned timelines:
*Admin frills (price certificates, letters of authorisation, registration status, copy of EU SmPC,
application forms that require signatures from sites etc)
*Checks that all documents are present, requests D-number and requests publishing if required
*Ensures that the complete required data package is stored correctly on the SDA
*Notifies LOC of the location of the electronic copy of the data package
*Organises despatch of hard copies of data package components to the LOC, where originals are
required
*Updates record in OPAL with despatch date and D-number
*Follows relevant processes and standards
*Provides resource analysis to senior staff to ensure obligations can be met
*Keeps up to date on regulatory requirements and escalates changes through the relevant
process
Competencies and Capabilities
*Most activities will follow defined and established criteria that follow local regulatory
requirements. In some instances, interpretation of and application to local guidance
information is expected (20%)
*In addition to following established procedures, individual will be required to interact with
senior staff for guidance and direction
Experience, Skills and Specialized Knowledge Required
Basic Qualifications:
*Proficient level of appropriate Regulatory experience
*Demonstrated self-motivation and ability to work with diverse customer groups to support
customers
*Demonstrated ability to proactively manage workload, timelines and identify prioritise
*Proven ability to work on multiple projects and submissions/reports simultaneously
*Demonstrates the ability to bring complex assignments through to completion
Preferred Qualifications:
*Bachelor degree or appropriate qualifications / experience
*Knowledge of key activities external to Regulatory impacting on requirements
For more information please call James Harvey at Gold Group on 01342 330 515, or email your CV to james.harvey@goldgroup.co.uk
This advert was posted by Gold Group - one of the UK's leading niche recruitment consultancies. We span a variety of specialist industries and are the recruitment company to help you find your next career opportunity. We pride ourselves on our commitment to candidates and stick to our ethos of finding the right role for the right person. Visit our website or get in touch today to discuss this role, find out what else we've got or just for a chat about the state of your industry. Services advertised by Gold Group are those of an Agency and/or an Employment Business.
