Regulatory Affairs Team Lead
Location: Flexible. We can accommodate candidates either home-based or office based with flexible working. Our Head-office is in Stratford, East London.
Salary range: £60-70k dependent on experience
Cancer Research UK’s Centre for Drug Development (CDD) is a centre of excellence in early phase cancer drug development. We bring our drug development expertise together with innovators in science and medicine to deliver more treatment options to cancer patients. We have a pioneering portfolio of first-in-class and first-in-human agents under active development including small molecules, antibodies, imaging agents, cell therapies and vaccines.
Our Regulatory Affairs team consists of 6 regulatory affairs professionals involved throughout the lifecycle of our projects, developing bespoke regulatory strategies during preclinical development through to submission of our final CSRs and summary trial results. As part of a multi-disciplinary project team, our Regulatory Affairs Managers are involved in IMPD development, seeking scientific advice from the MHRA and overall coordination of the CTA and subsequent amendments for our broad portfolio of cutting edge therapeutics. In addition, the team lead our regulatory intelligence network within the CDD and frequently contribute to regulatory consultations.
The Regulatory Affairs Team Lead is a management position. You will manage the regulatory team and use your significant specialist knowledge and experience to represent CDD and CRUK on regulatory matters and be accountable for the regulatory team output. As their line manager you will ensure that they are continuously developed and able to deliver on agreed project timelines.
In order to be considered for the role, you must meet all the following:
Experience of working in early phase clinical trials
Able to apply specialist regulatory knowledge and experience to support the regulatory aspects of early phase drug development in the Charity, improve processes and instil best practice
An understanding of the different aspects of drug development (preclinical and clinical)
Experience of writing and reviewing IMPDs and other regulatory documents, including ability to interpret and accurately summarise complex scientific data for inclusion in regulatory packages.
Excellent knowledge of current Clinical Trial Legislation specifically UK and EU and particularly in relation to first-in-man trials.
Experience of interacting directly with regulatory agencies, in particular the MHRA.
Able to assess and effectively communicate information within project teams and to senior managers. Influence colleagues and project teams to gain consensus and provide constructive feedback.
You can find out more about the role by viewing this candidate pack.
Application process: There is no closing date for this role. We are eager to move at pace and will be reviewing applications on a regular basis and inviting suitable candidates to interview prior to the closing date. We reserve the right to withdraw the advert at any time, so please do not delay your application to avoid disappointment.
Please note there is no closing date. Please click here to apply: https://cancerresearchuk.wd3.myworkdayjobs.com/External_Careers/job/Stra...