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Location: London, UK

Reporting to: Director of Advanced Analytics

Job Summary

The CMC Technical Documentation Specialist will be a member of the Global Technical Development team and will be responsible for preparing and drafting CMC source documents for use in global regulatory filings such as Investigational New Drug (IND) Applications, Investigative Medicinal Product Dossiers (IMPD), and CMC sections of Health Authority Meeting Briefing Books. This position will require close cross-functional collaboration with the CMC functions and the Regulatory CMC team and will have full accountability to drive continuous improvement in the process of source document creation with the goal of streamlining the translation of these technical documents into regulation filings. This is an exciting opportunity for a well-qualified candidate to join a global company with a diverse and dynamic work environment focused on transforming the lives of patients with rare disorders through innovative gene therapies.

Key Elements and Responsibilities

· Lead preparation meetings to define the strategy for source document structure and content

· Prepare and draft CMC source documents for use in global regulatory filings

· Ensure that CMC source documents are complete, accurate, and they comply with current regulatory requirements

· Prepare and coordinate the review and approval of CMC documents

· Collaborate with colleagues to interpret and summarize data, and support CMC regulatory strategy

· Drive the development, continuous improvement and maintenance of CMC documentation processes, best practices, and procedures