Regulatory Affairs Specialists
Pharmaceutical CMC, Contract Research and Development
Salary: Attractive. Negotiable
Location: North East England
Our client is a major contract research and development organisation that is continuing to expand its operations throughout the world. An exciting opportunity has arisen for two individuals to join their team of CMC scientists, engaged in drug development activities.
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 company clients
You should be qualified to a minimum of degree level in a relevant scientific subject and have at least 2 years; experience producing CMC regulatory documents
Excellent written/oral communication and interpersonal skills together with a good knowledge of early phase, CMC regulatory requirements are essential.
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