UK ~ Nottingham
Regulatory Affairs Lead
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 at the site in Nottingham for a Regulatory Affairs Lead. In this role, you will be ultimately responsible for leading and coordinating regulatory submissions (CTA applications, ARSAC applications & Research Ethics Committee (REC) submissions) as part of a wider project team. As a Regulatory Affairs Lead, you will also be responsible for the authoring and review of clinical documentation prepared for submission, and will compile and submit applications and perform maintenance activities throughout the lifecycle of a clinical study conducted at Quotient Sciences.
The Regulatory Affairs Lead is fundamental to the success of the business. You will drive continuous quality improvement initiatives relating to regulatory submissions, Ethics, and ARSAC submission processes and act as point of contact for Regulatory Authorities.
This role comes with fantastic career development opportunities. If you would like to join a fast paced and dynamic business and make a difference in early phase drug development, then this is the role for you.
The successful candidate will be educated to a minimum degree level in a biological or life science discipline, coupled with previous regulatory experience in a similar role in a pharmaceutical company or CRO. Experience of US IND and eCTD submissions is also desirable although not essential.
Other skills and experience required:
- Possess detailed knowledge of relevant regulations & guidance and ability to critically analyse and apply knowledge to develop innovative regulatory solutions to arising issues
- Proven project leadership and team work ability
- Ability to juggle a range of tasks/ issues simultaneously
- Ability to work to strict and tight deadlines
- Possess high quality standards and attention to detail
- Be a confident and articulate communicator (both written and verbal), with the ability to convey and present highly complex information to others clearly and logically
- Demonstration of effective communication with regulatory authorities
- Being customer focused and ability to respond to sponsor requirements
This role can be based at either site in Nottingham, or Reading, with some flexibility of home working (dependent upon your level of experience).
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.