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CMC Regulatory Specialists and Project Managers

Date Posted: 19/6/2018
Application Close: 17/8/2018
Location: Arcinova - Alnwick
Description:

The successful applicants will have experience of preparing CMC regulatory documentation for early clinical phases and familiarity with the drug development process.

The role will include:

  • The coordination, production and review of early clinical phase CMC regulatory documentation prior to their submission to global regulatory agencies
  • Acting as project manager and client point of contact, for assigned CMC projects
  • Participating in discussions with potential clients and assisting in the preparation of regulatory documentation related work proposals
  • Preparing and assisting in the preparation of selected CMC documentation types such as release monographs
  • Providing API and drug product related CMC regulatory advice to colleagues and ARCINOVA clients
  • Working flexibly to meet ARCINOVA business needs

Excellent written/oral communication and interpersonal skills together with a good knowledge of early phase, CMC regulatory requirements are essential.