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Job Details

Senior Associate Regulatory Operations - Cambridge

Company: CK Clinical
Location: Cambridge
Reference: CL41300
Closing Date: 14 Mar 18
Type: Contract
Salary (£): 60,000 - 80,000

Job Summary:

Mary Bolt is recruiting for a Senior Associate Regulatory Operations to join a world leading pharmaceutical company at their site based in Cambridge on a...


Mary Bolt is recruiting for a Senior Associate Regulatory Operations to join a world leading pharmaceutical company at their site based in Cambridge on a 12 month contract basis.

The main purpose of the role will be to:
-Facilitate product development and global registration through the efficient preparation and management of regulatory documentation, information and systems.
-Maintain regulatory document management systems and tracking systems, maintain core dossier components and be responsible for quality control of regulatory dossiers, archive and tracking systems.
-Electronic document management of ongoing submissions (e.g. building dossier structure, sourcing documents) and incoming and outgoing agency correspondence.

Further responsibilities will include:
-Archiving of regulatory submissions and agency correspondence and document management of core dossier components for Emerging Market submissions.
-Day to day oversight and work allocation to other team members and training of staff on process change as well as management of individual projects and management of Regulatory Information Projects.
-Sourcing of submission dossier components and data entry as well as administration of and reporting from regulatory registration tracking system.

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 experience in Regulatory Information Management.
-Document Management Experience and ideally familiarity with regulatory processes and procedures in International regions.
-Attention to detail, time and project management skills, good written and verbal communication skills, results orientated and proficient in Word, Adobe Acrobat, EDM/Documentum, Outlook, MS Excel, MS PowerPoint.

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 CL41300 in all correspondence.

Apply for this job: Senior Associate Regulatory Operations - Cambridge

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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