Regulatory Affairs Manager

Quotient Sciences is a leading drug development and manufacturing accelerator, helping biotech and pharma companies bring new medicines to patients faster. With over 35 years of experience and a track record of success, we provide Drug Product (CDMO) and Clinical (CRO) services across the entire development pathway, including formulation development, clinical pharmacology, clinical trials, and commercial product manufacturing.

Our proprietary and disruptive platform – “Translational Pharmaceutics®” – integrates Drug Product Manufacturing and Clinical Testing to eliminate silos in the drug development process. This in turn reduces costs, improves outcomes, and significantly accelerates drug development times.

Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact—fast.

Quotient Sciences has an exciting career opportunity for a Regulatory Affairs Manager. This role can be home‑based, office‑based at our UK clinical research unit in Nottingham, or be a hybrid role (at least 3 days a week on site). If home‑based, we would ask you to occasionally visit the Nottingham site, where our Regulatory Affairs team is based.

As a Regulatory Affairs Manager, you will lead regulatory activities supporting the fast‑paced, phase 1 and phase 2 clinical trials of potential new medicines conducted in our Nottingham clinical unit, and phase 2 trials at NHS sites. You will obtain and maintain clinical trial approvals from the Medicines and Healthcare products Regulatory Agency (MHRA), Research Ethics Committees (RECs), Health Research Authority (HRA) and the Administration of Radioactive Substances Advisory Committee (ARSAC) and use your knowledge of applicable regulations and guidelines to advise clients and colleagues on regulatory strategy and compliance.

The Regulatory Affairs Manager is fundamental to the success of the business. You will contribute to continuous quality improvement of regulatory processes and act as point of contact for regulatory authorities.

This role comes with fantastic career development opportunities. If you would like to join a fast‑paced and dynamic business and make a difference in early phase drug development, then this is the role for you.

• Act as Regulatory Lead for cross‑functional teams
• Responsible for planning, coordination and timely delivery of regulatory clinical trial submissions (e.g. initial Combined Review submissions to the MHRA and RECs, HRA submissions and local capability and capacity assessments, ARSAC applications), and managing post‑submission and post‑approval activities, such as responses and amendments
• Prepare, review and QC key trial documents
• Prepare, collate, and submit clinical trial applications
• Act as point of contact for sponsors, MHRA, RECs, HRA, NHS Trusts and ARSAC
• Lead regulatory discussions in project meetings and advise project teams and sponsors on regulatory matters
• Liaise with MHRA, RECs, HRA, and ARSAC, and negotiate innovative and practical responses to their feedback
• Provide significant input into and/or management of continuous quality improvement initiatives and processes relating to regulatory activities
• Mentor colleagues and deliver training in regulatory processes
• Participate in sponsor audits and inspections by regulatory authorities
• Keep up‑to‑date and continue to extend knowledge of relevant laws and guidance
• Support business development activities

The successful candidate will be educated to at least degree level in a life science subject (or have equivalent relevant experience) and have several years’ regulatory experience in a similar role in a pharmaceutical company or CRO. The ideal candidate will have experience of managing the regulatory approval of commercial phase 2 trials at NHS sites and phase 1 trials in healthy volunteers.

• Thorough knowledge and understanding of the regulations and guidance underpinning UK clinical trials, and ability to apply knowledge to develop innovative and practical regulatory…