Company: SEC Recruitment
Closing Date: 07 Dec 16
Salary (£): 80,000 - 100,000
Senior Associate Regulatory AffairsContract: 6 monthsCambridgeshire or BerkshireThe fantastic job opportunity has arisen within one the world’s largest biotechnology companies. You would be working to bring state-of-the-art medicines from the laboratory to the patient. With a history of over 30 years, the company has pushed the existing limits to deliver exciting therapies to medical teams around the world. ...
Senior Associate Regulatory Affairs
Contract: 6 months
Cambridgeshire or Berkshire
The fantastic job opportunity has arisen within one the world’s largest biotechnology companies. You would be working to bring state-of-the-art medicines from the laboratory to the patient. With a history of over 30 years, the company has pushed the existing limits to deliver exciting therapies to medical teams around the world.
You will lead, or provide assistance with, the creation and submission of regulatory documents, and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead.
Role and responsibilities:
• Prepare and maintain CTA/MA documentation in collaboration with Regional Regulatory Lead
• Produce and maintain product regulatory history documents and appropriately archive all regulatory documents and agency communications
• Ensure compliance through timely submissions to regulatory agencies
• Initiate process improvement, standards development and metrics
• Deliver regulatory support to Commercial, Medical and Clinical departments through internal interactions
• Correspondence with GRT reporting relevant issues and responding to specific requests
• Produce regulatory packages and cross-reference letters to assist investigator initiated studies
Required skills and qualifications:
• Degree in a relevant scientific field (or similar) is required
• Master’s degree (or higher) is a preference
• Broad EU clinical trial application experience is essential
• Understanding of drug development process, e.g. clinical trial phases
• Strong communication skills – oral and written
• Organizational and time management skills
• Experience in oncology therapeutic area (preferred)
Don’t miss this fantastic opportunity to work with one of the world’s leading biotech companies.
To find out more information about this role please contact Elena on +44 207 255 6600 or send your CV to firstname.lastname@example.org.
3rd Floor, 13-15 Moorgate London.
|Tel:||00 44 (0) 207 255 6600|
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