Regulatory Publishing Consultant

£0.00 - £30 per hour
  1. Permanent
  2. Publishing & Submissions
  3. United Kingdom
Cambridge, England
Posting date: 22 Oct 2019
RA.PD.25987_1571761517

An international staffing and recruiting company is currently recruiting a Regulatory Publishing Consultant to join their office in the UK. This organisation is one of the largest workforce management solutions companies in the world who specialise in multiple scientific and engineering sectors. This is an exciting opportunity to work with a firm dedicated to innovative and dynamic approaches to the changing workforce landscape.

Job Responsibilities:

  • Working as part of a global Regulatory Operations team, both leading and contributing to global filings.
  • Leading key submissions for EU, CAN, MENA and Emerging Markets,
  • Compiling and publishing submission dossiers for clinical trials, paediatrics, and marketing applications.
  • Working closely with submission content providers to advise on submission content, structure, planning, and strategy.
  • Working with publishing vendors.
  • Reviewing Regulatory submission source documents, formatting, and 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.
  • Preparing submission ready components from source documents according to regional regulatory agency guidance
  • Document managing ongoing submissions, e.g. building dossier structure, sourcing documents.
  • Overseeing quality control of submission ready components and submission dossiers.
  • Preparing, dispatching, and tracking electronic and paper media.
  • Maintaining submission information in Regulatory Registration Tracking system.

Skills and Requirements:

  • Bachelor's degree, or equivalent combination of education and experience.
  • Specialist knowledge of pharmaceutical/biotech industry gained in operationally focused role.
  • Demonstrated experience with Insight Publisher including associated publishing, validation, and review tools.
  • Working with publishing vendors.
  • Working in matrix environment.
  • Dossier and Submission related Regulatory Guidance for EU, MENA, and the Emerging Markets.
  • Successful submission and maintenance of marketing applications in multiple regions.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Peter Duvall at +44 203 078 9542 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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