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Job Location | London |
Education | Not Mentioned |
Salary | £550.00 - £660.00 per day |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Contract, full-time |
Senior Regulatory Affairs Executive | Operational and Strategic | UK&I | 6 Month Initial contract Your New Company A Japanese pharmaceutical company is looking for a driven Senior Regulatory Affairs Executive to offer operational/technical support to the UK&I Regulatory team. for one of their products. This is a great opportunity to gain exposure within a global company with a wide variety of approved products across Oncology, Gastroenterology, and Neuroscience.Your New Role You will be joining the UK&I Regulatory Affairs team as the Senior Reg Affairs Executive to help maintain existing and obtaining new MAs in UK and Ireland to support the strategy and commercial activities. You will be Responsible for maintaining of existing and new MA in the UK and I, registered via national, MRP, DCP, and Centralised procedures. You will prepare updated product information texts, ensuring they are clear and accurate for submissions, and ensure quality standards are consistently met and submissions are made to deadlines. What you will need to succeed You will have a minimum of 8-10 years within a regulatory affairs role in the pharmaceuticals industry. You will have experience preparing and submitting post-marketing regulatory applications to the MHRA and HPRA. You will have experience wiring and updating documents, including labelling and artworks. You will also have previous experience working with eCTD and NeeS submission formats. What you will get in returnThis is an initial 6-month initial contract, with scope for extension. The location is London with flexible working, and offering £550-660 per day in scope of IR35, 37.5 hours per week. What you need to do nowIf this role is something you may be interested in please click "apply now" to forward on an updated version of your CV.