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Location: Newcastle upon Tyne
Duration: 4 months
Reg Affairs (RA) Specialist
A great opportunity has come up to join a global life science company at their site in Newcastle, initially on a 4 month basis as a regulatory affairs specialist. The main purpose of the role is to facilitate registrations globally, facilitate product market withdrawals, liaise with competent health authorities, facilitate product registration renewals and manage submissions to support global registrations. This role is suitable for candidates with some industry exposure to Regulatory Affairs, although full training will be provided, some experience in this field or a related discipline is not absolutely necessary.
Main responsibilities will include:
• Assisting with product registrations in EU, Middle East and Africa
• Responsible for registration, notification and assist in file preparation of the entire LBS product portfolio according to local regulatory requirements, where appropriate
• Review and provide input into STED/CSTD/Tech Files.
• Manage, monitor and promote continuous improvement activities through the use and implementation of DBS tools to ensure processes are evaluated constantly for effectiveness.
• Assist with Global Regulatory Intelligence and input into regulatory newsletter.
• Liaison with SU, legal and Regulatory Bodies as required.
Ideally, candidates will be educated to degree level (or equivalent) in a life science field, or related discipline. The successful applicant will have had some exposure in industry to regulatory filings or IVD/Device regulations. If this sounds like you, apply with your CV now, and feel free to contact Tom Kirkpatrick at CY Partners for more information.
The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK. CY Partners Recruitment Ltd, trading as CY Partners is an Employment Business/Agency.
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