Senior Regulatory Affairs Manager
UK ~ Nottingham
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 help biotech and pharma customers save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,200 talented individuals globally, located at state-of-the-art development, manufacturing, clinical and data sciences 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.
We have an exciting opportunity for a Senior Regulatory Affairs Manager. This role can be home-based, office-based at our UK clinical research unit in Nottingham, or utilise hybrid working. If home-based, we would ask you to occasionally visit the Nottingham site, where our Regulatory Affairs team is based.
As a Senior Regulatory Affairs Manager, you will lead regulatory activities supporting the fast-paced, phase 1 clinical trials of potential new medicines conducted in our Nottingham clinical unit. You will obtain and maintain approval from the Medicines and Healthcare products Regulatory Agency (MHRA), ethics committees and the Administration of Radioactive Substances Advisory Committee (ARSAC). You will use your excellent knowledge and detailed understanding of relevant regulations and guidance to critically analyse emerging issues and find innovative regulatory solutions, to advise other regulatory leads and sponsors on regulatory strategy, and to negotiate with regulators.
The Senior Regulatory Affairs Manager is fundamental to the success of the business. You will drive continuous quality improvement of regulatory processes, and act as point of contact for regulatory authorities. There will be potential to line manage, or develop line management skills, depending on your experience.
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.
Main tasks and responsibilities:
- Act as regulatory lead within a cross-functional team;
- Responsible for timely delivery of regulatory submissions (CTA, Ethics & ARSAC), and post-submission activities, including management of substantial amendments and urgent safety measures;
- Act as point of contact for sponsors, MHRA, Research Ethics Committees (RECs) and ARSAC;
- Author, review, compile and submit regulatory applications, supported by our team of Regulatory Officers and Associates;
- Provide strategic advice to project teams, other regulatory leads and sponsors;
- Liaise with MHRA, ethics committees and ARSAC, and negotiate innovative and practical responses to their feedback;
- Assist sponsors in obtaining scientific advice from the MHRA;
- Drive continuous quality improvement initiatives relating to regulatory activities, and develop and maintain processes;
- Help to develop colleagues through mentoring and training;
- Keep up-to-date with changes in regulations and guidance;
- Participate in business development activities relating to clinical regulatory services, including bid defence presentations.
The successful candidate will be educated to at least degree level in a life science subject (or have equivalent relevant experience), and have substantial previous regulatory experience in a similar role in a pharmaceutical company or CRO, ideally in early phase research in the UK. Experience of US IND and eCTD submissions is also desirable although not essential.
Other skills and experience required:
- Excellent knowledge and detailed understanding of the regulations and guidance underpinning UK clinical trials
- Demonstrated ability to critically analyse problems and find innovative regulatory solutions
- Proven project leadership and teamwork
- Excellent organisational skills and ability to manage a range of tasks and projects simultaneously
- Able to work to strict and tight deadlines
- Able to work to high quality standards with excellent attention to detail
- Confident and effective communicator (both written and verbal), and able to convey and present highly complex information to others clearly and logically
- Proven effective communication with sponsors and regulatory authorities
- Customer focused
- Experience of effective line management would be an advantage
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.