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Job Details

Senior Regulatory Affairs Manager, UK and Ireland in Cambridge

Company: CK Clinical
Location: Cambridge
Reference: CL44302
Closing Date: 01 Feb 19
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

Laura Durrell is recruiting for a Senior Regulatory Affairs Manager - UK and Ireland to join a privately owned Pharmaceutical company bringing innovative medicines to UK...

Requirements:

Laura Durrell is recruiting for a Senior Regulatory Affairs Manager - UK and Ireland to join a privately owned Pharmaceutical company bringing innovative medicines to UK health professionals and their patients at their site based in Cambridge on a permanent basis.
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The Company:
Our client is an innovative, privately owned pharmaceutical company with an interesting product portfolio and a focus on providing high-quality medicines.
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The Location:
The role is based at our client's site in Cambridge, a town famous for its history, university and architecture. There is also the added benefit of being accessible to London and Stanstead and Luton airports.
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The Role:
The main purpose of the role will be to:
· Ensure that new marketing authorisations (MAAs) are secured according to the needs of the UK and Irish business and maintained.
· Make strategic regulatory decisions in line with the business priorities and needs.
· Act as the key interface for regulatory affairs with health authorities and key stakeholders.
· Provide regulatory direction and support to product launch and commercialisation activities including artwork, labelling etc.
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Further responsibilities will include:
· Maintaining and extending solid relationships with UK MHRA and Irish HPRA to support UK/Ireland and European RA matters smoothly.
· Supporting the Head of Pharmacovigilance & Regulatory Affairs in UK/Ireland ensuring relevant processes are in place.
· Helping with the oversight and management of any outsourced activities including the preparation and management of audits and inspections by authorities.
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Your Background:
To succeed in this role, you will come from a background in:
· Educated to degree level or above in life science or a related field with proven success within Regulatory Affairs in the UK and Ireland.
· Established credibility with regulatory agencies and demonstrable success in influencing HA.
· Strong leadership and communication skills and the ability to build rapport and demonstrate strong influencing and negotiation skills.
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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 CL44302 in all correspondence.

Apply for this job: Senior Regulatory Affairs Manager, UK and Ireland in Cambridge

Contact Information:

Address:  Head Office
9 High Street
Stevenage
Hertfordshire
SG1 3BG
England
Tel:  +44 (0)1438 743047
Fax:  +44 (0) 1438723800
Website:  Visit Our Web Site

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