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Job Details

Regulatory Affairs Manager - London

Company: CK Clinical
Location: London
Reference: CL40153
Closing Date: 01 Nov 17
Type: Contract
Salary (£): Competitive

Job Summary:

Mary Bolt is recruiting for a Regulatory Affairs Manager to join a company in the pharmaceutical industry at their site based in Central London on...


Mary Bolt is recruiting for a Regulatory Affairs Manager to join a company in the pharmaceutical industry at their site based in Central London on a contract basis.

The main purpose of the role will be to:
- Compile core regulatory packages for use in EU clinical trial applications and compile complete CTAs for submission to UK and IE Competent Authorities.
- Provide appropriate oversight of Service Providers making CTA submissions
- Assist the Head of Regulatory Affairs with the compilation of Investigational New Drug application documentation for submission to the US FDA

Further responsibilities will include:
- Representing Regulatory Affairs at Study Team meetings
- Ensuring filing of clinical trials documentation is kept up-to-date and compliant
- Reviewing work orders and invoices to ensure correct billing of activities

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 equivalent experience within the pharmaceutical industry
- Extensive experience of regulatory affairs within the EU and US and focusing on regulatory clinical trial applications
- Excellent communication skills and ability to liaise with health authorities

This is an excellent opportunity to join a small and innovative pharmaceutical company.

Benefits include an excellent hourly rate of between £50-£60phr for a Limited Company Contractor.

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 CL40153 in all correspondence.

Apply for this job: Regulatory Affairs Manager - London

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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