Company: CK Clinical
Closing Date: 28 Oct 16
Salary (£): Competitive
Oliver Care is recruiting for a Project Manager - Regulatory Affairs to join a biopharmaceutical company with a varied product portfolio focused on developing cutting-edge therapies...
Oliver Care is recruiting for a Project Manager - Regulatory Affairs to join a biopharmaceutical company with a varied product portfolio focused on developing cutting-edge therapies and innovations at their site based in Maidenhead on a permanent basis.
The main purpose of the role will be:
-To obtain marketing authorisation's for new pharmaceutical products in the UK and Malta where appropriate
-Maintaining marketing authorisation's as required.
-To gain regulatory authority approval for new clinical trials and amendments to such trials undertaken by the company in the UK and Malta as appropriate.
Further responsibilities will include:
-Liaising with European Regulatory Affairs and Corporate groups on regulatory issues.
-Liaising with external regulatory authorities as required.
-Drafting of packaging texts, SmPCs, PILs and Prescribing Information.
-Reviewing of material in accordance with The Prescription Medicines Code of Practice Authority (PMCPA)/ABPI Code.
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 relevant scientific discipline.
-Must have experience in regulatory affairs including clinical trials and promotional material review.
-Must have effective project management skills
This is an excellent opportunity to join a global biopharmaceutical company developing high quality products across the world.
CK Clinical is an Equal Opportunities employer who 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 CL36723 in all correspondence.
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