Regulatory Affairs Manager
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 Manager. In this role, you will be ultimately responsible for leading and coordinating regulatory submissions (CTA applications, ARSAC applications and Research Ethics Committee (REC) submissions) as part of a wider project team. As a Regulatory Affairs Manager, 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 Manager 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 and 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 is remote (WFH) working home. Our UK clinical research unit is in Nottingham. You are welcome to visit either of our UK sites in Nottingham, Reading or Edinburgh if you would like to occasionally work from the office.
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.