UK ~ Nottingham
Regulatory Affairs Officer
Our growing and successful business comprises of over 850 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.
Quotient Sciences have an exciting career opportunity for a Regulatory professional who is looking for the next step in their regulatory career. As a Regulatory Affairs Officer you will work within a small team of regulatory professionals based at our Nottingham site, and will support the Regulatory Affairs Manager by undertaking the following duties.
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 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 team work 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.