Company: Worldwide Clinical Trials
Location: Home Based - Any EU country
Closing Date: 12 Nov 16
Salary (£): On Application
Exciting opportunity within a leader global CRO which provides full drug development services to the pharmaceutical and biotechnology industries from Early Phase and Bioanalytical Sciences through Phase II and III trials to peri-approval studies. The company is looking for a Senior Specialist or Manager Regulatory Affairs to join their expanding Clinical Study Start-Up and Regulatory Affairs group.
Worldwide Clinical Trials (WCT) currently have a permanent vacancy to support activities due to new projects. Experience in Global submission is required.
Senior Regulatory Specialist,, Global Regulatory Affairs, Senior Regulatory Associate. Regulatory Affairs Specialist.
Full-time permanent position for a Senior Specialist or Manager who will provide regulatory oversight to clinical studies awarded to Worldwide across regions for all stages of the drug development cycle (from phase I to IV) and will ensure the smooth running of the Regulatory Affairs activities within studies.
•Effectively and rapidly coordinate & manage CTA submissions to regulatory authorities and ethics committees and maintain approvals throughout EMEA, Asia Pacific and Latin America regions
•Ensure high quality performance of deliverables are applied within the projects assigned and promptly identify and address any risk/potential risk by implementing preventive measures
•Provide regulatory strategic advice to internal and external customers
•Contribute towards the preparation and/or review of technical documentation (i.e. protocol, IMPDs and IBs) when required
•Review and, if applicable, customise all relevant documentation (i.e. labels, patient information sheets, diary cards, insurance etc) to ensure high level of quality and compliance with ICH GCP & country specific requirements
•Assist RA-BIDs and senior management in securing new business or repeated business by participating to BDMs, developing/ reviewing regulatory sections of proposals and regulatory costing and budgets
•Provide coaching, advice and mentoring to regulatory members assigned to the projects (although the position will not have any direct line management responsibilities)
SKILLS AND EXPERIENCE:
•Bachelor's Degree in Chemistry or Life Sciences, Nursing or equivalent experience
•Minimum 7 years within pharmaceutical/CRO industry, of which at least 5 years as regulatory lead in global clinical trials
•Proven ability to successfully manage global projects in start-up
•Excellent organizational and management skills
•Outstanding written and verbal communication skills and interpersonal skills
•Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment
•Ability to exercise sound judgment and make decisions independently
•Expert knowledge of ICH GCP and the EU Clinical Trials Directive/Regulation and National regulations (CTAs, Amendments, Urgent Safety Measures, End of Trial Notifications)
•Expert knowledge of drug development
Advantageous, experience in one of these 2 areas:
•CMC experience on Biological products
•Preparation of CTA submissions in APAC countries
Regulatory, Regulatory Affairs, Regulatory Manager, Regulatory Senior Specialist, Regulatory Officer, Regulatory Lead, CRO, Clinical Start-Up, Biotechnology, Biotech, Clinical Trials, CMC, APAC, regulatory submissions
Worldwide Clinical Trials
2nd Floor 172 Tottenham Court Road London
|Tel:||0207 121 61 61|
|Website:||Visit Our Web Site|
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