Senior Regulatory Executive - 65199

Job Ref: J24427
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 highlighting potential delaying factors promptly to line management and sharing knowledge of regulatory documentation and procedures with others to assist in problem solving.

Key Responsibilities:

  • Development of regulatory strategy for key initiatives proposed by the manufacturing part of the business including sourcing changes on the API and Drug Product.
  • Provision of regulatory advice to colleagues in the manufacturing organisation.
  • Creation and maintenance of regulatory plans.
  • Interface with other regulatory departments within Global Regulatory Affairs.
  • Preparation/Authoring of regulatory dossiers Market Specific Requests to support key manufacturing initiatives including source changes.
  • Identify improvement opportunities for CMC Regulatory processes, policies and systems.
  • Provide feedback on progress and challenges to key stakeholders.
  • Contribute to the maintenance of global CMC regulatory intelligence.
  • Preparation of high quality, Chemistry, Manufacturing and Control detailed regulatory documents using varied information sources.

Skills/Experience Required:

  • Minimum 5 years strong CMC experience - authoring mandatory.
  • Be aware of the contents of a marketing authorization application
  • Detailed proven CMC Regulatory knowledge and experience for EU, US and EMAP region
  • Understands CMC regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global CMC applications.

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.