Regulatory Affairs Associate in Nottingham

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.

This is a fantastic opportunity to join our Regulatory Affairs team as a Regulatory Affairs Associate. Clinical trials are highly regulated and must be conducted to the highest standards of safety, science and ethics. Before each clinical trial starts, it must be reviewed and approved by the Medicines and Healthcare products Regulatory Agency (MHRA) and an independent ethics committee; approval from the Administration of Radioactive Substances Advisory Committee (ARSAC) is also needed if the trial involves exposure to ionising radiation. Meticulous records must be kept to demonstrate compliance with regulations and international guidance. Our Regulatory Affairs team is responsible for obtaining and maintaining approval for our trials and for providing strategic regulatory advice to our clients.

In this role, you will be an integral part of the Regulatory Affairs team, supporting our Regulatory Affairs Officers and Managers in obtaining and maintaining approvals from the MHRA, ethics committees and ARSAC.

As a Regulatory Affairs Associate, you will be principally responsible for:

• Creating and reviewing Quotient and client submission documents;
• Preparing, compiling and coordinating clinical trial applications to the MHRA and ethics committees;
• Assisting with clinical trial submissions to the Administration of Radioactive Substances Advisory Committee (ARSAC);
• Liaising with ethics committees to ensure timely approval;
• Assisting with post submission and post approval activities, including responding to questions from the authorities, making amendments to trials, submitting reports to the authorities, and end of trial activities;
• Ensuring that comprehensive and accurate records are retained in our investigator site file;
• Supporting the team in maintenance of standard operating procedures and other ad hoc duties;
• Developing your knowledge of the UK regulations and guidelines on clinical trials.

This is an entry-level role in Regulatory Affairs. The successful candidate will be educated to degree level in a life science subject and wish to pursue a career in Regulatory Affairs within the pharmaceutical industry.

Other skills and experience required:

• Strong written and verbal communication skills and the ability to liaise and negotiate with ethics committees;
• Able to communicate with, and present effectively to, internal project teams and clients where required;
• Able to convey and present scientific information clearly and logically in lay language;
• Able to interpret and practically apply regulations and guidelines;
• Good problem-solving and decision-making skills;
• Excellent organisational skills and able to work independently, managing your own workload effectively across several projects simultaneously;
• Able to work to tight deadlines and under pressure;
• Able to work to high quality standards with excellent attention to detail;
• Good teamwork, able to build constructive relationships within the team and the company and externally;
• Previous experience of working within clinical research or a Contract Research Organisation would be an advantage, but is not essential, as full training will be given.

Applicants must have the right to work in the UK at the time of being offered employment. This role will be based at our site in Nottingham, with some home working.

To apply, submit a CV and a cover letter.

Please note that this position is not eligible for sponsorship under the UK points-based immigration system. If you require sponsorship, we will be unable to progress your application or make an offer of employment. As this is a permanent role, we are also unable to accept applications from candidates on a Graduate Visa.

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.

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.