Senior Regulatory Executive - 65171

Job Ref: J24428
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 21 November 2017
  • West London, London, England, UK
  • Competitive
  • Natasha Rollason

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The Role:

Responsible for preparation of high quality, Chemistry, Manufacturing and Control detailed regulatory documents using varied information sources. Working to agreed deadlines and maintaining records to reflecting project status.

Key Responsibilities:

  • Respond to manufacturing site change controls and providing regulatory advice and strategies.
  • Identify improvement opportunities for CMC Regulatory processes, policies and systems.
  • Understand CMC regulations, guidelines, procedures and policies relating registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global CMC applications.
  • Manage multiple project assignments/teams simultaneously and provide data assessment and conclusions.
  • Identify risks associated with submission data and information packages and ability to propose mitigation actions.
  • Efficiently interact with customers and senior stakeholders as required.
  • Contribute to process improvement and/or regulatory intelligence projects.
  • Responsible for highlighting potential delaying factors promptly to line management and sharing knowledge of regulatory documentation and procedures with others to assist in problem solving. Proactively pursuing process improvement and sharing of best practice.

Skills/Experience Required:

  • Post Approval CMC experience preferential.
  • CMC authoring experience essential. This should include authoring of module 3 and authoring of CMC variations.
  • Detailed proven CMC knowledge and experience for EU and EMAP region.

Education

Minimum graduate level, with a relevant biologically based scientific background.

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

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.