Regulatory Affairs Manager

Job Title:Regulatory Affairs Manager
Location UK ~ Nottingham
UK ~ Homebased
Type: Full Time, Permanent

Company Overview

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients.

As a growing and successful business, we employ more than 1,200 talented individuals globally, located at state-of-the-art development, manufacturing, clinical and data sciences facilities in the UK and USA.

Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.

The Role

Quotient Sciences have 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 utilise hybrid working.  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 clinical trials of potential new medicines conducted in our Nottingham clinical unit.  You will obtain and maintain approval from the Medicines and Healthcare products Regulatory Agency (MHRA), ethics committees 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.

Main tasks and responsibilities:

  • Act as regulatory lead within a cross-functional team;
  • Responsible for timely delivery of regulatory submissions (CTA, Ethics & ARSAC), and post-submission activities;
  • Author, review, compile and submit regulatory applications, supported by our team of Regulatory Officers and Associates;
  • Act as point of contact for sponsors, MHRA, Research Ethics Committees (RECs) and ARSAC;
  • Provide strategic advice to project teams and sponsors;
  • Liaise with MHRA, ethics committees and ARSAC, and negotiate innovative and practical responses to their feedback;
  • Provide input into continuous quality improvement initiatives and processes relating to regulatory activities;
  • Mentor colleagues and deliver training in regulatory processes;
  • Keep up-to-date with changes in regulations and guidance;
  • Support business development.

The Candidate

The successful candidate will be educated to at least degree level in a life science subject (or have equivalent relevant experience), and have previous regulatory experience in a similar role in a pharmaceutical company or CRO, ideally in early phase research in the UK. Experience of US IND and eCTD submissions is also desirable although not essential.

Other skills and experience required:

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

Company benefits

In return, you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.

Our Commitment to Diversity & Inclusion

Quotient Sciences are advocates for positive change and conscious inclusion.

We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.

As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. All applicants welcome.