Regulatory Site Officer

Regulatory Professionals
South East England
£350 day rate
02 Dec 2017
08 Dec 2017
Contract Type
Full Time
Regulatory Site Officer
South East Ireland
9 month contract
£350 day rate
Job Ref: J31559

A leading pharmaceutical organisation is seeking a Regulatory Site Officer to join their team on a 12 month contract basis. This position will involve the review and approval of cGMP regulatory reports and protocol submissions. The ideal candidate will be able to demonstrate strong knowledge of working within CMC, quality management systems, cGMP and compliance.

Key Responsibilities include, but are not limited to:
* Review and approval of appropriate documents including PMF and SMF.
* Communicate proposed CMC changes for prioritisation
* Represent the site at global Regulatory Affairs meetings
* Ensure compliance to cGMP at all times
* Ensure, via corporate RA-CMC, that compliance is not compromised between country requirements and actual site practices

Application Requirements:
* At least 3-4 years` experience
* Competent at dealing with regulatory authorities in EU, US and/or similar markets
* Extensive CMC and cGMP experience
* Experience working as a QP in release of products to market
* A background in manufacturing operations and dealing with Regulatory authorities

Alternatively, if you know someone that may be interested in this role then please feel free to pass this advertisement on and if they are successfully place then you`ll receive £250 worth of vouchers of your choice.
Regulatory, good manufacturing practice, CMC, manufacturing, Ireland, Republic of Ireland, South-East Ireland.