Regulatory Knowledge Specialist

Job Ref: J33709
Sector: Clinical
Sub-sector: Pharmaceuticals
Job Type: Contract
Date Added: 09 October 2019
  • Berkshire, England, UK Berkshire Berkshire UK SL1 3WE
  • Competitive
  • Natasha Rollason

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Our Client a Global Pharmaceutical Company has opened a new vacancy within there Regulatory team and are looking to recruit a Regulatory Knowledge Specialist on a 12 month contract to be based at their offices in Slough.

The Role:

Analyse, remediate and disseminate information held in regulatory databases so that the company is able to maintain and manage its diverse product portfolio. Suggest modifications to known procedures and processes to overcome issues in an effective and time-efficient manner; use initiative in improvising and identifying new approaches to work practices; maintain current awareness of new technology and incorporate the department's goals into the proposed solution.

Key Responsibilities/Requirements:

  • Provide first-line business support and end-user training for use of internal global license tracking database and document management system. End Users include Global Regulatory Affairs, Technical Operations, Drug Safety, Affiliates and Strategic Partners
  • Correct data/content quality issues as needed in alignment with published conventions
  • Follow up with the end users regarding identified data or content quality issues and identify areas for improvement in process documentation and/or training
  • Performing quality control checks and proof reading on data entered into internal global license tracking and Regulatory Submissions databases
  • Authoring, Reviewing and Approving documents including Validation Deliverables, SOPs, Release Notes, User Guides, Protocols, Reports and FAQs
  • Representing the application user community, providing input into User Requirements and information on related processes and systems interfaces
  • Supporting data providers and consumers with queries about data definitions, quality standards and other similar aspects
  • Communicate concerns, issues and problems to individuals to data owners and governance bodies that can influence change
  • Support with Health Authority Submissions, Inspections and Correspondence activities
  • Implement controlled vocabularies on a rolling basis that aligns with Product Master Data Strategy and IDMP requirements
  • Deviation and CAPA management, Audit readiness and audit/inspection support

Skills/Experience Required:

  • Degree in any life sciences.
  • 3+ years of experience in the pharmaceutical industry, with specific experience related to the processing of regulatory information management.
  • Minimum of 2 years of experience in the supporting end users to enter and maintain product information in a registration tracking database
  • Extensive knowledge of regional regulatory agency requirements as they relate to maintenance of product information and submission tracking
  • Extensive knowledge of registration tracking technologies, document best practices related to system usage, archiving, and tracking

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673

08/11/2019 15:51:43