Regulatory Expert in Residence opportunity

Overview & context

An exciting opportunity has arisen for a Regulatory Expert in Residence (REiR) to be hosted in the Faculty of Medicine, Dentistry and Health at the University of Sheffield as a consultant to help address a gap in researcher knowledge of regulatory affairs with regard to medical devices, including medical software, and therapeutic development. The REiR will be recognised as a “Visiting Academic” and be funded as a consultant.

The aim of the post-holder will be to inform/guide researchers of the anticipated regulatory needs associated with an early stage potential new medical intervention progressing to market and to plan accordingly, and not necessarily to ensure the early stage research is compliant, which is generally not possible in a University environment.  The role will suit an outgoing, experienced and knowledgeable regulatory consultant keen to provide regulatory support to such early stage translational projects in a University/NHS Trust environment to demystify medical regulatory requirements and the associated documentation.

The awardee will spend 1day per week (or equivalent) over 1 year working with researchers directly and provision of training sessions with regulatory advice and aspects relating to progressing their research towards patient benefit and the market in the broad healthcare remit. The appointee will receive a stipend/honorarium of £20,000 for this position and be designated a “Visiting researcher” at the University (the post-holder will not be a formal member of University of Sheffield staff). The role can be home based anywhere in the UK. It is anticipated that the regulatory support provided will be delivered primarily online via 1:1 or group training workshops and face to face (where appropriate and safe to do so as per University guidelines).

Further information on the University of Sheffield, the Faculty of Medicine, Dentistry and Health and the Healthcare Gateway can be found on https://www.sheffield.ac.uk, http://www.shef.ac.uk/medicine and http://shg.sheffield.ac.uk/home.aspx.

Applicants  should provide a cover letter and resume/ cv indicating why they are interested in the role and describing their suitability in terms of experience and expertise as outlined in the person specification below.

Person Specification

Applicants should provide evidence that they meet the following criteria. We will use a range of selection methods including reviewing your application letter and cv, seeking references, inviting shortlisted candidates to (an online) interview and other forms of assessment action relevant to the post.

About the Team

The Faculty of Medicine, Dentistry and Health (http://www.sheffield.ac.uk/faculty/medicine-dentistry-health) brings together the strengths of six research departments covering Clinical Dentistry, Infection, Immunity and Cardiovascular Disease, Health and Related Research (ScHARR), Health Sciences School, Oncology and Metabolism and Neuroscience. The Faculty and University have a strong track record of developing and bringing research to market, collaborating with industry, conducting clinical trials and providing training to the health professional sector. The University and the Faculty are committed to continuing and increasing such knowledge exchange & commercialisation activities.

Visiting academic post description

Main Duties and Responsibilities

• To provide regulatory expertise and training to researchers and professional services to help support the research, development and commercialisation of medical devices and therapies across the broad MRC healthcare remit
• To advise on the regulatory strategy of early stage healthcare translational projects, the regulatory hurdles that are likely to be encountered and the work needed to overcome them
• To provide individual and group (online) training sessions in regulatory needs in the broad healthcare remit
• To support development of costed regulatory strategies that support commercialisation of University IP via spinouts and third-party licences
• To articulate the regulatory requirements for new products and changes to existing products being utilised for a different purpose than the intended purpose
• To provide guidance on the compilation of technical files and inform on requirements associated with regulatory submissions including appropriate quality standards for submissible work
• Be able to engage and communicate with key health authorities such as MHRA, EMA, NICE, FDA
• Determine the scope of information/documentation necessary to file new registration applications and post-approval changes to regulatory agencies
• Develop short guidance documents for researchers and professional staff
• Be familiar with new and existing regulations (UK/EU/US), guidance documents and standards, and to indicate how this may impinge on specific translational efforts
• Be aware of requirements for internal and external company regulatory/quality audits
• Be able to interact with all levels of University staff as well as frequent interactions with various external regulatory agencies
• To provide recommendations and updates to senior management on progress of the work

Remuneration

Terms and conditions of employment: The postholder will receive a stipend/honorarium and be designated a “Visiting researcher” at the University. The appointee will not be employed by the University of Sheffield nor will be a formal member of University of Sheffield staff. 

Stipend/ Honorarium: £20,000.

This post is fixed-term with a start date 1 February 2021 or as soon as possible thereafter for a period of 12months.

This post is part-time: This role will be part-time at 0.2FTE and the awardee will spend 1day per week (or equivalent) over 12months to provide (online) training and helping researchers with regulatory advice for grant applications and/or commercialization activities to help progress their findings towards patient benefit and the market in the broad healthcare remit. The role can be home based anywhere in the UK and it is anticipated that interactions with researchers and staff will be online. Should circumstances and University guidelines permit in the current COVID19 pandemic, there will be an expectation to travel to Sheffield.
 

Selection – Next Steps

Response deadline: The closing date for this post is 4^th Jan 2021.

Applicants  should provide a cover letter and resume/ cv indicating why they are interested in the role and describing their suitability in terms of experience and expertise and send this when applying below.

Following the closing date, you will be contacted by email to let you know whether or not you have been shortlisted to participate in the next stage of the selection process.

Interviews are provisionally scheduled for 14 January 2021.

Informal enquiries

For informal enquiries about this opportunity, contact: Dr Sue Smith by email sue.smith@sheffield.ac.uk