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Job Details

EMEA Regulatory Affairs Manager - Oncology - High Wycombe

Company: CK Clinical
Location: High Wycombe
Reference: CL41870
Closing Date: 11 Jun 18
Type: Permanent
Salary (£): 60,000 - 80,000

Job Summary:

Mary Bolt is recruiting for an EMEA Regulatory Affairs Manager - Oncology to join a highly established research-based pharmaceutical company with a mission to change the...


Mary Bolt is recruiting for an EMEA Regulatory Affairs Manager - Oncology to join a highly established research-based pharmaceutical company with a mission to change the way diseases are managed, interpreted, and prevented at their site based in High Wycombe on a permanent basis.

The main purpose of the role will be to:
-Support all regulatory activities associated with the development, post-approval and life-cycle management for designated products within the Oncology portfolio.
-Provide regulatory content support for products by interacting with project teams, LOCs and regulatory agencies (as appropriate) and supporting submissions as appropriate.
-Provide guidance and support to product development teams on regulatory issues.

Further responsibilities will include:
-Communicating with Regulatory Agencies as needed and assisting in the preparation of meetings with Regulatory Agencies.
-Contributing to the definition and development of new processes, standards or operational plans in support of the organisational/ business strategies, with a direct impact on business unit/function overall results.
-Preparing, holding and leading cross functional team meetings as appropriate and developing an understanding of the regional regulatory environment, competitor intelligence and therapeutic area.

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 life science or a related field with all round general regulatory affairs experience, a sound understanding of the drug development process and a detailed knowledge and familiarly of the European and EMEA regulatory framework.
-Excellent interpersonal, verbal and written communication skills as well as relationship building skills.
-Knowledge of how Health Authorities operate and a good general knowledge of HA organizational structure and individual responsibilities in those structures

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 CL41870 in all correspondence.

Apply for this job: EMEA Regulatory Affairs Manager - Oncology - High Wycombe

Contact Information:

Address:  Head Office
9 High Street
Tel:  +44 (0)1438 743047
Fax:  +44 (0) 1438723800
Website:  Visit Our Web Site

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