Regulatory Affairs Manager
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 twelve month contract to be based at their London office when lockdown guidelines have eased.
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, represent or attend Regulatory Authority meetings as appropriate, respond to questions from Regulatory Authorities and coordinate and track responses from and to Competent Authorities.
- Ensuring that filing of clinical trials documentation is kept up-to-date and compliant and keep a tracker of events up to date to ensure adherence to agreed timelines.
- Liaising with study team members on issues relating to RA and attend relevant internal/external meetings which involve RA matters and may include bid meetings.
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.
Entitlement to work in the UK is essential. For more information please contact Hendre Moolman on 01438 842 970 or email firstname.lastname@example.org. Please quote reference 48517 in all correspondence.
It is essential that applicants hold entitlement to work in the UK