Associate Director, Regulatory Affairs
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 a fantastic career opportunity for an Associate Director, Regulatory Affairs. This is a remote role allowing you to work from home anywhere in the UK!
As the Associate Director, Regulatory Affairs, you will be responsible for the provision of an efficient and effective regulatory submissions service for the company, ensure strategic regulatory support and expert advice to the company and sponsors as appropriate and ensuring compliance with relevant existing and emerging legislation and guidance.
Main tasks and responsibilities:
- Provision of regulatory advice on clinical trial submission strategies within the company
- Provision of expert advice on requirements for information for clinical trial applications
- Provision of other expert regulatory advice and guidance as necessary to the company and the sponsor as required
- Further development of the regulatory affairs services offered by the company
- Management and continued development of the regulatory submissions processes
- Development of appropriate timelines for clinical trial submissions in conjunction with the relevant project/ programme manager
- Effective communication with staff and sponsors on regulatory affairs issues
- Liaison with the MHRA, ethics committees and ARSAC as required
- Monitoring of the outcome of regulatory submissions including analysis of requests for information, grounds for non-acceptances and so on, to ensure appropriate learnings are implemented
- Experience of authoring Investigator Brochure’s
- Authoring, reviewing and approval of IMPDs as appropriate prior to submission
The successful candidate will have minimum of degree level in a science subject, or equivalent, extensive previous work experience in regulatory affairs in the EU, preferably in the UK. You will have tthorough knowledge and understanding of Clinical Trial Applications in the UK/ EU.
Other skills and experience required:
- Some knowledge of regulatory requirements and submissions in other territories e.g., USA and Japan, would be advantageous
- Membership of TOPRA or another appropriate regulatory affairs organisation
- Previous line management 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.
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.