Regulatory Affairs Associate - Cambridge

CK Clinical
£20000 to £30000
13 Nov 2017
16 Nov 2017
Contract Type
Full Time
Mary Bolt is recruiting for a Regulatory Affairs Associate to join a leading, privately owned, global pharma with significant presence in several therapeutic areas at their site based in Cambridge on a permanent basis.

The main purpose of the role will be to:
-Support the day-to-day submission readiness activities of submission documents within the Regulatory Affairs electronic document management system and create and maintain ongoing regulatory activities and details in the Regulatory Affairs tracking database.
-Prepare submission-specific 'envelope' documents with appropriate support, prepare virtual documents within the regulatory electronic document management system, where appropriate and create and import documents into the regulatory electronic document management system on behalf of the functional teams to aid the content authors.
-Ensure that documents required for submission to regulatory authorities are properly formatted, reviewed/ approved, tracked and retrieved according to regulatory guidelines and internal business procedures.

Further responsibilities will include:
-Raising issues related to area of expertise with the line manager and/or appropriate Regulatory Affairs Sub-Team members and perform actions to address these issues, as agreed.
-Working as a team player and performing all reasonable tasks related to regulatory activities in accordance with the priority settings as well as ensuring that the appropriate departmental procedures and standards of good regulatory practice are employed.
-Attending and participating in appropriate learning events for both personal and professional development and developing and document new working practices as appropriate.

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 sciences or a related field and some experience of working in Regulatory Affairs in the Pharmaceutical industry.
-Strong administration and organisation skills and experience in the use of Word, Excel and PowerPoint and flexibility to learn new IT systems e.g. electronic databases and document management systems.
-Take personal responsibility, ownership and accountability for decision marking, problem solving and managing regulatory projects and maintain high attention to accuracy and detail.

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 CL40527 in all correspondence.