Quotient Sciences have an exciting career opportunity for a Senior Director of Regulatory Affairs to head up the regulatory function at the site in Nottingham. The Regulatory Affairs department currently consists of a team of 10 regulatory professionals. With a number of direct reports, you will be responsible for strategically leading the Regulatory Affairs department, line managing and inspiring the team, whilst driving continuous quality improvement relating to regulatory processes.
The Quotient Regulatory function provides a centralised service coordinating regulatory submissions (CTA applications, ARSAC applications & Research Ethics Committee (REC) submissions) for clinical studies conducted by Quotient Sciences. With the expansion of the Quotient business and the acquisition of US facilities, the role will also involve development of regulatory strategies to support US IND submissions.
As the Senior/Director, Regulatory Affairs, you will ensure compliance of the Regulatory Affairs Department with relevant legislation and guidance and support the wider business in providing regulatory strategy and advice for new business.