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CMC Regulatory Specialists and Project Managers
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.