Senior Regulatory Operations Associate

Location
Homeworking
Salary
Negotiable
Posted
10 May 2021
Closes
24 May 2021
Ref
SNRASSOREGOPS
Contact
Guy Shipman
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Senior Regulatory Operations Associate - Submission Management - 30696

12 month contract - 37.5 hours per week

£32.22 per hour maximum pay

Office base preference in Cambridge - flexibility to be afforded

Highly innovative Biopharmaceutical company

Description

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, 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.

This is a fantastic opportunity to join a high performing European team in an organisation focused on talent development.

Responsibilities include:

  • 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

Minimum requirements:

  • Degree or equivalent combination of experience and knowledge
  • Minimum of 3-4 years of 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

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