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| Job Location | London |
| Education | Not Mentioned |
| Salary | Salary negotiable |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Contract, full-time |
CK Clinical are recruiting for a Regulatory Affairs Manager to join a highly successful pharmaceutical company with a strong portfolio of marketed and developmental products. This will be a 12 month contract. Initially you will be working from home but you must be prepared to be based at their London office as they reopen in the new year (plus 1-2 days home working).Regulatory Affairs Manager Role:The main purpose of the role will be to:- Ensure that all clinical trial applications and other clinical development activities meet current regulatory requirements/guidelines both in the EU and the US and check for any new updates in legislation and regulatory guidance.- Compile core regulatory packages for use in EU clinical trial applications, compile complete CTAs for submission to UK and IE Competent Authorities and provide appropriate oversight of Service Providers making CTA submissions.- Plan and provide support for the compilation of Investigational New Drug application documentation for submission to the US FDA.Further responsibilities will include:- Representing Regulatory affairs at study team meetings.- Keep a tracker of events up to date to ensure adherence to agreed timelines.- Prepare appropriate Regulatory documents as required for the successful development of a drug to marketing authorisation e.g. fast track applications, orphan, PIPs etc.- Represent or attend Regulatory Authority meetings as appropriate.- Respond to questions from Regulatory Authorities.- Review work orders and invoices to ensure correct billing of activities.Your Background:In order to be considered for this role, you will be required to have the following qualifications, skills and experience:- Educated to degree level or above in life science or a related field with demonstrable RA experience gained within a contract research organisation (CRO), pharmaceutical, or Biotechnology Company.- Extensive experience of regulatory affairs within the EU and US particularly around clinical trial applications with an understanding of GCP and clinical trials application processes in the UK.- Excellent communication skills and ability to liaise with health authorities as well as being able to interact effectively at all levels within the organisation and with external partners and clients.Apply:For more information or to apply for this Regulatory Affairs Manager position, please contact CK Group, quoting job ref 49401.It is essential that applicants hold entitlement to work in the UK.