Company: TEC Group International
Closing Date: 13 Mar 17
Type: Full Time
Salary (£): 40,000 - 60,000
For more information please contact Sam Murphy via email firstname.lastname@example.org / 0208 544 3423
We have two roles available in the same team for Senior Regulatory Associate or Regulatory Associate Manager level professionals (depending on experience level), with a global Biopharmaceutical company based in Cambridge.
This is a truly innovative and science focused Regulatory Affairs group, therefore to thrive in this environment you must share the same motivation and passion for innovative science. The successful Regulatory professionals will encounter a fast paced, varied workload working on an international basis, across the entire lifecycle.
The successful candidates will spend 70% of their time working with high profile marketed products undertaking global post approval activities. The other 30% of the role will include working on new development products, preparing and/or co-ordinating the regulatory documentation to support clinical trial applications/ amendments, scientific advice procedures and paediatric investigational plans (pip) for development compounds where required.
Degree in life sciences, pharmacy or medicine (or international equivalent)
Experience of either post-licensing OR clinical trials work, is mandatory to apply with some experience mentioned below:
• Experience in the preparation/submission of regulatory documentation to support variations renewals, variations, responses to questions from health authorities, PSURs etc for Centralized products. Centralized MAA experience.
• Experience in the preparation/submission of regulatory documentation to support clinical trials applications/amendments in the European Union and good breadth of understanding of European regulations relating to clinical trials.
• Experience representing Regulatory Affairs on cross functional teams is mandatory.
A small amount of travel to Europe and the US may be required.
Dowgate Hill House, 14-16 Dowgate Hill, London
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