0403-23 – Regulatory Affairs Consultant

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RKE – Research
Location: 
Aston University Main Campus
Salary: 

£54,421 to £82,227
per annum
Contract Type: 
Fixed Term

(31/03/2025)
Basis: 
Full Time
Closing Date:  23.59 hours BST on Friday 09 June 2023
Interview Date: 
Tuesday 20 June 2023
Reference:  0403-23
Release Date:  Thursday 25 May 2023

Aston University is currently seeking an experienced Regulatory Affairs Specialist to act as a consultant for the West Midlands SPARK Programme, modelled after Stanford’s model for preclinical acceleration. This exciting position provides a unique opportunity to contribute to the dynamic field of healthcare innovation, playing a crucial role in driving and facilitating preclinical development projects led by academics, clinicians, and regional companies.

SPARK is a unique partnership between university and industry founded by Professor Daria Mochly-Rosen in 2006 at Stanford University in USA. The purpose is to provide the education and mentorship necessary to advance research discoveries from the bench to the bedside. SPARK provides access to specialised knowledge and technical expertise regarding drug and diagnostic development and sources of funding to support translational efforts.

You will support the on-boarding process for a diverse portfolio of preclinical projects onto the SPARK programme, ensuring appropriate regulatory strategies are developed that give each project the best chance at reaching clinical trial stage, or market authorisation where clinical trials are not required. This will include making sure the regulatory strategy of these projects stands up to due diligence carried out by educated investors.

You will do this by utilising your experience in at least one of the following three fields; Diagnostics Development, Medical Device Development (Minimum Class 2) or Therapeutics Development. You will have specific experience working with the Research and Development teams of companies in the sector.

You will be expected to collaborate closely with a broader consortium of stakeholders, fostering growth and advancement of the regions bio/medtech sector. This will involve providing ad-hoc consultancy to regional SMEs and groups not necessarily part of the SPARK Programme. 

Where possible you will partner with the SPARK project manager and project teams to streamline the onboarding process onto the SPARK programme, assisting them in creating robust, industry-standard pathways compliant with existing regulations.

If you wish to further discuss this role please contact Luke Southan ([email protected] ).

Anonymous shortlisting will be carried out for this role as part of Aston University’s commitment to equality and diversity and ensuring a fair and consistent approach to recruitment. Personal details that are included on application forms, including the candidate’s name and address will not be disclosed to the shortlisting panel. CVs will not be considered as part of the shortlisting process

Interview Date: 19/06/2023 and 20/06/2023

Aston University is an equal opportunities employer and welcomes applications from all sections of the community.  It promotes equality and diversity in all aspects of its work. We strive to have robust inclusivity strategies in place, including race and sexual orientation, to encourage colleagues to have the confidence and freedom to be themselves in the workplace. For more information, visit: https://www2.aston.ac.uk/about/inclusive-aston

If you require the job details document or an application form in an alternative format please contact the recruitment team at [email protected]