Regulatory Affairs Associate I

at  Quotient Sciences

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.
We employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical 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 that’s focused on innovation and are 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
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 it starts, each clinical trial 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. We support the fast-paced, early phase clinical trials of potential new medicines conducted in our Nottingham clinical unit.
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;
• Maintaining our Regulatory Affairs database;
• 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.

The Candidate
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.
  Application Requirements
  When applying for a position with Quotient Sciences to be able to work in our organisation 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.
  Our Commitment to Diversity, Equity and Inclusion
  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 organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today.
  Specifically we will not discriminate on the basis of race, colour, 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

• 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;
• Maintaining our Regulatory Affairs database;
• 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