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Regulatory Affairs Manager

Location: West Molesey Salary: Negotiable
Sector: Regulatory Affairs Type: Permanent
Contact: Simon Cowley Job Published: 12 days ago

My client is seeking an enthusiastic and hands-on Regulatory Affairs Manager to help us to fulfil our clinical development ambitions. This is an exciting opportunity to make a significant impact on the development of emerging projects and establish a Regulatory Affairs function.

The successful candidate will be involved in process development, production, quality, project management, pre-clinical and clinical (functions represented both within the company as well as external consultants and CROs), the authoring of DMFs, IMPDs, clinical trial applications, INDs, etc. and ensuring a compliant regulatory correspondence file is maintained. o

You will support our enthusiastic product developmetn team, working with our Head of Quality to interpret the regulatory requirements demanded by early clinical development and ensure that reports and data meet the required standards of all external agencies.

You will be responsible for regulatory liaison with external agencies including point of contact, arranging and chairing meetings, and managing all interactions to meet the needs of the company.

The successful professional will possess at least four years working in a regulatory affairs environment, in early clinical development. As this is a highly technical manufacturing environment, experience of compiling IMPDs and working with manufacturing professionals is essential.

If you meet this criteria and are a highly motivated, flexible and quick thinking RA professional who is able to adapt to an exciting and rapidly evolving cutting edge field in addition to being a skilled communicator with the ability to multi discipline teams together, please apply ASAP

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