UK ~ Nottingham
Associate Regulatory Affairs Officer
Our growing and successful business comprises of over 900 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing. We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
This is a fantastic opportunity to join our growing Regulatory Affairs team as an Associate Regulatory Affairs Officer. In this role, you will be an integral part of the Regulatory Affairs Department supporting the Regulatory Affairs Manager and others in the preparation coordination and submission of regulatory applications (CTA, Ethics and ARSAC) as well as ensuring that the quality of these submissions is maintained as appropriate throughout the lifespan of the study.
As the Associate Regulatory Affairs Officer, you will be principally responsible for preparing, compiling and coordinating Ethics and ARSAC Submissions in the UK and liaising with these agencies to ensure timely approvals. You will be responsible for reviewing Quotient and client submission documentation and handling all post submission activities including responding to questions from the authorities, amendments and end of trial activities. You will also be required to create regulatory submission documents where required.
Other duties include supporting the Regulatory Affairs Manager on compilation and filing of CTAs and maintaining the Regulatory Affairs Database and to support the Regulatory Affairs Department with SOP maintenance and any ad hoc duties where necessary.
This is an entry-level role into Regulatory Affairs. The successful candidate will be educated to degree level in a life science subject and possess a strong desire to work in Regulatory Affairs within the pharmaceutical industry.
Other skills and experience required:
- Strong written and verbal communication skills and possess the ability to liaise and negotiate with the regulatory authorities;
- Ability to communicate with and present effectively to clients where required;
- Ability to convey and present scientific information clearly and logically in lay format;
- Ability to interpret and practically apply regulations and guidelines;
- Good problem solving and decision making skills;
- Ability to work independently and manage your own workload, whilst working effectively on number of projects simultaneously;
- Ability to work to deadlines and under pressure
- Ability to work to high quality standards and possesses a high level of attention to detail;
- Good team player building constructive relationships both within the company and externally.
- Previous experience of working within a clinical research or a Contract Research Organisation would be desirable, 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.
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.