Regulatory Affairs Manager

The Regulatory Affairs Manager you will Act as Regulatory Lead in obtaining regulatory (MHRA), ethics and ARSAC approval for phase 1 clinical trials at Quotient Sciences, and for any phase 1/2 trials managed by Quotient Sciences. Comply with relevant regulations and guidance (including GXP guidelines) as required of this role and continue to develop awareness and understanding of the regulations and guidelines that underpin clinical trials

Main tasks and responsibilities

• Act as Regulatory Lead for cross-functional teams
• Responsible for coordination, planning and timely delivery of regulatory submissions (e.g. initial Combined Review submission to the MHRA and ethics committees, applications for review of studies that are not clinical trials of investigational medicinal products (non-CTIMPs), ARSAC applications, RFI responses and amendments)
• Prepare, review, and QC key trial documents
• Prepare, collate, compile and submit initial Combined Review submissions for review by the MHRA and ethics committees, and ARSAC applications, and manage post-submission and post-approval activities, such as RFI responses and substantial amendments
• Act as point of contact for sponsor, MHRA, Research Ethics Committees (RECs) and ARSAC with regard to submissions, and negotiate innovative and practical solutions to comments arising from MHRA, Ethics Committees and ARSAC
• Lead regulatory discussions in meetings with sponsors and cross-functional Quotient teams
• Advise colleagues on regulatory matters, such as decisions on whether amendments are substantial
• Manage urgent safety measures, with support
• Participate in review of serious breaches
• Provide significant input into and/or management of continuous quality improvement initiatives and CAPA relating to MHRA, Ethics and ARSAC submission processes
• Contribute to regulatory team meetings
• Provide training to colleagues in role-specific tasks
• Mentor Regulatory Affairs Managers, Regulatory Affairs Officers and Regulatory Affairs Associates
• Participate in sponsor audits and inspections by regulatory authorities
• Support business development activities relating to regulatory services for specific proposals

• Maintain Regulatory group folders, regulatory section of investigator site files and Regulatory Database

• Perform general regulatory administrative tasks as required
• Keep up to date and extend knowledge of relevant laws and guidance

Qualifications and experience required for competent performance

• Educated to at least degree level or equivalent in a life science discipline (or have equivalent training and experience)
• Several years’ relevant regulatory experience in a pharmaceutical company or CRO
• Thorough knowledge of relevant laws and guidance and their application to Phase 1 clinical trials
• Proven ability to support regulatory applications and act as Regulatory Lead for trials
• Project leadership and teamwork ability
• Ability to communicate clearly and effectively (both written & verbal) with internal colleagues and sponsor teams
• Ability to devise innovative and practical solutions to comments arising from Ethics Committees, the MHRA and ARSAC
• Maintain high quality standards, attention to detail and ability to work simultaneously on multiple projects and tasks
• Proven ability to prioritise and cope with a high workload

Application Requirements

When applying for a position with Quotient Sciences to be able to work in our organisation you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.

Our Commitment to Diversity, Equity and Inclusion

Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today.

Specifically we will not discriminate on the basis of race, colour, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.

This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.