UK ~ Nottingham
Senior Regulatory Affairs Manager
Our growing and successful business comprises of over 800 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 Senior Regulatory Affairs Manager. In this role, you will act as Regulatory Lead in providing a centralised service coordinating regulatory submissions (CTA applications, ARSAC applications & Research Ethics Committee (REC) submissions) for clinical studies conducted by Quotient Sciences.
As the Senior Regulatory Affairs Manager, you will line manage members of the Regulatory Affairs Department, drive continuous quality improvement relating to regulatory processes.
Main tasks and responsibilities include:
- Acting as Regulatory Lead for clinical studies with responsibility for timely delivery of regulatory submissions (CTA, REC & ARSAC) as agreed with study sponsors
- Leading and co-ordinating, authoring, compiling and submitting CTA applications and post-submission activities
- Leading / overseeing REC submissions and post-submission activities
- Leading / overseeing preparation of ARSAC applications and maintenance activities
- Reviewing Quotient and sponsor documentation required for CTA applications and REC submissions and providing strategic advice to project teams and sponsors
- Acting as point of contact for Regulatory Authorities, RECs and ARSAC with regards to submissions
- Liaising with and negotiating innovative and practical solutions to comments arising from Regulatory Authorities, RECs and ARSAC
- Inputting into and management of continuous quality improvement initiatives relating to regulatory submissions, Ethics and ARSAC submission processes
The successful candidate will be educated to a minimum degree level in a biological or life science discipline, coupled with substantial 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
- Experience of effective line management
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.