Achieva Group Ltd

Senior Regulatory Publisher

Location
Cambridgeshire
Salary
£30 - £34 per hour
Posted
16 Jun 2021
Closes
16 Jul 2021
Ref
BH-25649-3
Contact
Tim Barratt
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Summary 
 The Senior Associate is an experienced Regulatory Operations professional responsible for facilitating product development and global registration through the efficient preparation, management and tracking of regulatory documentation and submissions. 
Reporting to Sr Manager, GRAAS Operations, the core elements of this key role will include leadership of key filings in Europe and the Extended EU Markets including compilation, publishing and QC of submission dossiers for clinical trials, paediatrics and marketing applications. You will also have the opportunity to work as part of the global team on Marketing Applications for new products, so collaborative working will be paramount to your success in this role. 
 
Responsibilities 
 • Work as part of a global Regulatory Operations team, contributing to global filings 
• Lead key submissions for EU, Switzerland and Emerging Markets 
• Compilation and publishing of submission dossiers for Europe and the extended EU markets for clinical trials, paediatrics and marketing applications according to regional regulatory agency guidance 
• Work closely with submission content providers to advise on submission content, structure, planning and strategy 
• Submission management of publishing tasks sent to publishing vendors 
• Regulatory submission source document review, formatting, & troubleshooting, including but not limited to, MS Office, Adobe Acrobat PDF, Acrobat Plug-ins and XML ensuring documents conform to style guide and internal/external regulations 
• Document management of ongoing submissions, e.g. building dossier structure, sourcing documents 
• Quality control of submission ready components and submission dossiers 
• Preparation , dispatch and tracking of electronic and paper media 
• Maintenance of submission information in Regulatory Registration Tracking system 

Experience 
 
Degree or equivalent combination of experience and knowledge 
 
• Demonstrated regulatory publishing experience within the pharmaceutical industry; 
• Advanced knowledge of MS word and Adobe Acrobat 
• Use of specialist publishing software to prepare submissions – Insight Publisher preferred 
• Use of electronic document management systems 
• Understanding of Regulatory submission requirements 
 
This is a fantastic opportunity to join a high performing European team in an organisation focused on talent development