Regulatory Affairs Officer
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.
Quotient Sciences have an exciting career opportunity for a Regulatory Affairs Officer who is looking for the next step in their regulatory career. As a Regulatory Affairs Officer, you will work within a team of regulatory professionals and will support the Regulatory Affairs Manager by undertaking the following duties. This role can be home based with occasional travel to either site in Nottingham, Reading or Edinburgh.
Main tasks and responsibilities:
- Review of documentation to include Clinical Protocols and Investigator Brochures to ensure compliance with applicable regulatory requirements necessary for submission
- Author Clinical Trial Application forms and covering letters for the regulatory submission package
- Compile and submit Clinical Trial Authorisation application packages to the MHRA
- Review and compile Research Ethics Application packages, where applicable
- Author, review and compile Administration of Radioactive Substances Advisory Committee (ARSAC) submission packages where required (experience not essential as full training will be provided)
- Author, review and compile substantial amendment documentation where required
- Perform maintenance activities throughout the lifecycle of the clinical study
- Contact and liaise with the regulatory agencies as required
- The Candidate
- The successful candidate will be educated to a minimum degree level in a biological or life science discipline. Previous relevant regulatory experience in a pharmaceutical company or CRO is essential.
Other skills and experience required:
- Theoretical and practical understanding of regulations and guidance with the ability to analyse and apply knowledge where required
- Proven teamwork ability
- Ability to work on multiple tasks simultaneously and manage time successfully
- Ability to work to strict deadlines
- Excellent attention to detail
- Confident and articulate communicator (both written and verbal), with the ability to convey and present information to others clearly and logically
- Customer focused and an ability to respond to sponsor requirements in a timely manner
- Excellent working knowledge of Microsoft applications
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.