Regulatory Affairs Associate
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 save precious time and money in getting drugs to patients.
As a growing and successful business, 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, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
This is a fantastic opportunity to join our growing Regulatory Affairs team as a Regulatory Affairs Associate. 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 Regulatory Affairs Associate , 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 a 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.
This role will be based at our site in Nottingham, with some home working.
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.
If you have any questions or need some support with your application, we’d love to hear from you so contact our friendly team at firstname.lastname@example.org.