Director Regulatory Sciences - Buckinghamshire

C.K. Associates Limited
12 Apr 2018
20 Apr 2018
Contract Type
Full Time
Mary Bolt is recruiting for a Director of Regulatory Sciences to join a thriving and expanding life sciences consultancy at their site based in Buckinghamshire on a permanent basis.

The main purpose of the role will be to support and lead several large Marketing Authorisation Applications, and will include labelling development, working on clinical summaries and risk minimisation activities, with frequent interactions for presubmission activities with both EMA and national regulatory agencies. The position will also require leading the development of Orphan applications and PIPs, Accelerated and Conditional approvals.

This is an excellent opportunity to join a friendly, flexible and informal working environment with the chance to work on diverse and interesting projects.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
-Educated to degree level or above in biosciences/life sciences, preferably with a PhD and extensive work experience within the pharma/biotech industry in Regulatory and R&D roles.
-You must be enthusiastic, self-motivated, entrepreneurial, have an eye for detail, and work well in a team.
-Therapy area knowledge in Oncology, Haematology and Orphan Diseases would be preferable.
-Excellent communication skills

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL41719 in all correspondence.
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