Company: CK Clinical
Closing Date: 15 Nov 16
Salary (£): 20,000 - 30,000
Oliver Care is recruiting for a Regulatory Affairs Executive - CMC to join a pharmaceutical manufacturer at their site based in Middlesex on a permanent basis....
Oliver Care is recruiting for a Regulatory Affairs Executive - CMC to join a pharmaceutical manufacturer at their site based in Middlesex on a permanent basis.
The main purpose of your role will be:
-To write and review high quality documents for submission to National and EU Regulatory Health Authorities.
-Responding to the queries received from the regulatory bodies (MHRA, IMB and EMA) in a timely manner.
-Write and review responses to the Health Authority.
Further responsibilities will include:
-To liaise and co-ordinate with affiliates for preparation of submission.
-Pro-actively work with various departments to ensure submission dates are met.
-Performing monthly in-house tasks for licence update and audit.
-To be able to scan samples and documents; Filing and archiving including maintenance of Products, documents and logs.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
-Life Science Degree or equivalent.
-Must have some understanding on MHRA and EU Regulatory Requirements.
-Must have understanding or experience working within the CMC.
This is a fantastic opportunity to join a fun, innovative and fast paced environment.
CK Clinical 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 CL37098 in all correspondence.
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