Senior 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.
We have an exciting opportunity for a Senior Regulatory Affairs Manager. This is a home working role, allowing you to work remotely from anywhere in the UK!
The Senior Regulatory Affairs Manager will act as 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. You will also author and review clinical documentation prepared for submission and perform maintenance activities throughout the lifecycle of the clinical study conducted at Quotient Sciences.
You will possess and maintain detailed knowledge of relevant regulations & guidance and ability to critically analyse and apply knowledge to develop innovative regulatory solutions to arising issues. You will be required to drive continuous quality improvement relating to regulatory processes, line manage members of the Regulatory Affairs Department, and comply & adhere to GXP guidelines and regulations as required of this role.
Main tasks and responsibilities:
- Act as Regulatory Lead for designated cross-functional team.
- Act as point of contact for MHRA, Research Ethics Committees (RECs) and ARSAC with regards to submissions
- Responsible for timely delivery of regulatory submissions (CTA, Ethics & ARSAC) as agreed with the relevant Project/Programme Manager
- Lead co-ordinate / author, compile and submit CTA applications and post-submission activities
- Review Quotient and Sponsor documentation required for CTA applications and REC submissions and provide strategic advice to project teams and sponsors
- Lead / oversee REC submissions and post-submission activities
- Lead / oversee preparation of ARSAC applications and maintenance activities
- Liaise with and negotiate innovative and practical solutions to comments arising from MHRA, Ethics Committees and ARSAC
- Input into and management of continuous quality improvement initiatives relating to CTA, Ethics and ARSAC submission processes
- Maintain the Regulatory Group Folders / Database and associated documents as required
- Perform general regulatory administrative tasks as required
- Line manage members of the Regulatory Affairs Department as required
- Train members of the Regulatory Affairs Department as required
The successful candidate will be educated to a minimum degree level in a biological or life science discipline. You will have substantial previous regulatory experience in a similar role in a pharmaceutical company or CRO.
Other skills and experience required:
- Proven project leadership and team work ability
- Ability to communicate highly effectively (both written & verbal) with internal colleagues, sponsor teams and regulatory authorities
- Experience of effective line management
- Membership of TOPRA or other appropriate regulatory affairs organisation.
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.