Clinical Trials Regulatory Affairs Lead - Nottingham
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Are you a regulatory affairs professional with clinical development experience? Would you like to advance your career and oversee a small but expanding team with an organisation who are not necessarily looking for previous line management experience? If you would like to hear further, then please read on or get in touch.
The Regulatory Affairs Manager will oversee a small team (3), acting as Regulatory Lead in providing a centralised service coordinating regulatory submissions (CTA applications, ARSAC applications & Research Ethics Committee (REC) submissions) for clinical studies
- Acting as Regulatory Lead for clinical studies with responsibility for timely delivery of regulatory submissions (CTA, REC & ARSAC) as agreed with study sponsors
- Leading and co-ordinating, authoring, compiling and submitting CTA applications and post-submission activities
- Leading / overseeing REC submissions and post-submission activities
- Leading / overseeing preparation of ARSAC applications and maintenance activities
- Reviewing company and sponsor documentation required for CTA applications and REC submissions and providing strategic advice to project teams and sponsors
- Acting as point of contact for Regulatory Authorities, RECs and ARSAC with regards to submissions
- Liaising with and negotiating innovative and practical solutions to comments arising from Regulatory Authorities, RECs and ARSAC
- Inputting into and management of continuous quality improvement initiatives relating to regulatory submissions, Ethics and ARSAC submission processes
- BSc educated
- Proven experience in a similar position for a Pharmaceutical company or CRO.
- Some line management is beneficial, but not essential. We are looking for a dynamic individual rather than just line management.