A medium sized biotech company, at the forefront of gene therapy are currently looking for a Senior Regulatory Affairs Consultant to join their team in Cambridge for 12 months initially, with the intent to extend. The ideal candidate will have a minimum of 5 years’ experience within Clinical Trail Applications.
Key Skills and Responsibilities:
• Lead regulatory submissions for EU and Emerging Markets
• Ensure the maintenance of all Clinical Trial Applications
• Develop and implement regulatory strategies
• Obtain and maintain clinical trial and marketing authorisation approvals including responses to questions
• Experience with EMA/CHMP Clinical Trail Applications through to and including Market Authorisation Applications
• Experience with Regulatory Development – Phases I- IV
• Experience in marketing products and variation procedures
• Previously worked with a Regional Regulatory Lead
• Excellent communicational skills
• Minimum of 5 years’ experience
[please note, candidates without clinical trial application experience will not be considered for this role]
Full job description and company details are available upon application, apply below. This position is being dealt with by Danielle Hardy at meet, call on +44 (0) 2030196045 or email directly at firstname.lastname@example.org to discuss in confidence.
If this vacancy isn’t quite suitable for your experience, then we are currently working on a wide range of other positions too. Please apply through our website, or alternatively call Danielle Hardy to find out more.
Find out more about us at www.peoplewithchemistry.com