Regulatory Affairs Associate - Middlesex

CK Clinical
South East England
09 Mar 2018
15 Mar 2018
Contract Type
Full Time
Mary Bolt is recruiting for a Regulatory Affairs Associate to join a world leading pharmaceutical company at their site based in Middlesex on a 12 month contract basis.

The main purpose of the role will be to:
-Assist in the creation and submission of worldwide CMC regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead.
-Assist the Regional Regulatory Lead to support regional regulatory pre-filing activities (e.g. core CTA/IMPD development and submission, support for pre-MAA filing, regulatory authority meeting preparations) as well as providing and maintaining CTA/MA documentation support (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with the Regional Regulatory Lead.
-Create and maintain product regulatory history documents through IMR/rRISE and appropriately archive all regulatory documents and agency communications

Further responsibilities will include:
-Ensuring compliance via timely submissions to regulatory agencies.
-Coordinating the collection of functional documents in support of regulatory applications and coordinating the QC of regulatory documentation (e.g. briefing packages).
-Providing primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages) and preparing regulatory packages and cross-reference letters to support investigator initiated studies

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.
-Experience of working within Regulatory Affairs particularly within CMC/Module 3 and global submissions.
-Strong communication (oral and written) and organisational skills as well as an understanding of the drug development process.

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 CL41448 in all correspondence.

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