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.

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• 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.

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• Thorough knowledge and understanding of the regulations and guidance underpinning UK clinical trials, and ability to apply knowledge to develop innovative and practical regulatory solutions
  
• Proven ability to support regulatory applications and act as a Regulatory Lead
  
• Project leadership and teamwork
  
• Excellent organisational skills and ability to manage a range of tasks and projects simultaneously
  
• Able to work to strict and tight deadlines
  
• Able to work to high quality standards with excellent attention to detail
  
• Confident and effective communicator (both written and verbal), and able to convey and present highly complex information to others clearly and logically
  
• Customer focused
  

When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.

Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today.

Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.

This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.

Mid‑Senior level

Full‑time

Legal and Health Care Provider

Pharmaceutical Manufacturing