PW-7007 Senior Regulatory Affairs Associate

Expiring today

Recruiter
AXESS
Location
Berkshire
Posted
17 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
BACKGROUND London Blue-chip Pharma Company EU Regulatory 6 month contract / extension possibility Office based role, some homeworking PRIMARY DUTIES Preparation, organization and coordination of data / documents for submission to regulatory agencies. Identify potential problems and provide guidance to document authors or team members. Handle routine responses to data and information requests from regulatory agencies with minimal oversight. Provide review of clinical trial documents (protocols, ICFs, etc) as identified by applicable SOPs. Function independently on study teams, attend product team meetings and provide regulatory guidance on CMC, nonclinical and clinical issues. Assist with electronic compilation of regulatory submissions as required. Assist manager with formulation of regulatory strategy through research, analysis and evaluation of alternative approaches and makes recommendations to management on relative merits of each. QUALIFICATIONS / EXPERIENCE REQUIRED: Life science graduate with previous regulatory experience, preferably in European development. Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK. TO APPLY: For a confidential discussion please telephone Sukhveer Gill at AXESS Limited on 020 8560 2300. To apply, please send your CV to jobs@axess.co.uk quoting reference PW-7007. Keywords: Regulatory Affairs Associate / Interim Reg Affairs Officer / Regulatory Affairs Interim Associate / London Reg Roles / Contract Reg Associate / London based regulatory contract roles / EU Reg Roles / EU Regulatory Associate / London / UK ABOUT AXESS: AXESS has been operating since 1990 We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development We match professional candidates to the best permanent, contract and interim roles in the market Visit us at www.axess.co.uk

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