Head of Regulatory CMC
Our client is a major Contract Research and Development Organisation (CRDO), providing the pharmaceutical industry with a comprehensive range of services.
They are focused on Process Research, Development, Scale-Up and small scale manufacturing, including bioanalysis, DMPK, regulatory and consulting services, covering drug candidates in Development and launched to the Market.
The role will include:
- The provision of managerial and regulatory leadership for a team of scientists engaged in the preparation of global CMC regulatory submissions
- Actively coordinating, producing and reviewing CMC regulatory documentation
- Participating in discussions with potential CMC regulatory clients and assisting in the preparation of work proposals in this area
- Providing API and drug product related CMC regulatory advice to colleagues and company clients
- Providing regulatory advice and documentation to clients planning to attend meetings with regulatory agencies and supporting responses to regulatory questions
- Working flexibly to meet business needs
- Excellent written and oral communication skills together with good interpersonal and organisational skills are essential
The successful applicant will have an in-depth knowledge of small molecule CMC regulatory requirements across the clinical phases and sufficient knowledge of large molecule regulatory submissions to allow their preparation within the team.
Based: North East England
Salary: Negotiable + Benefits
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