Regulatory - Regulatory Affairs Manager

Quotient Sciences · Nottingham, England, United Kingdom

FULL TIME

Job Description

Quotient Sciences: Molecule to Cure. Fast.

Quotient Sciences is a leading drug development and manufacturing accelerator, helping biotech and pharma companies bring new medicines to patients faster. With over 35 years of experience and a track record of success, we provide Drug Product (CDMO) and Clinical (CRO) services across the entire development pathway, including formulation development, clinical pharmacology, clinical trials, and commercial product manufacturing.

Our proprietary and disruptive platform – “Translational Pharmaceutics®” – integrates Drug Product Manufacturing and Clinical Testing to eliminate silos in the drug development process. This in turn

reduces costs

, improves outcomes, and significantly accelerates drug development times.

Why join us

Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact—fast.

Our clinical research facility is based in Nottingham, but where you work can be flexible. Depending on your location, we’re open to onsite, hybrid or remote working arrangements.

The Role

Are you an experienced Regulatory Affairs professional who enjoys taking ownership of clinical trial submissions and working closely with sponsors, regulators and cross-functional scientific teams?

We’re looking for a Regulatory Affairs Manager – Clinical Trials to join our team in Nottingham and play an important role in supporting the delivery of fast-paced Phase I and Phase I/II clinical trials in our clinic.

As a Regulatory Lead, you’ll take responsibility for managing regulatory submissions and approvals, working with the MHRA, Research Ethics Committees, Health Research Authority and ARSAC. You’ll be a trusted regulatory partner to our sponsors and internal teams, providing practical advice, navigating regulatory requirements and helping studies progress efficiently from submission and approval through to reporting.

This is a great opportunity to further develop your regulatory expertise in early-phase clinical development while taking on increasing responsibility, mentoring colleagues and contributing to the continuous improvement of our regulatory processes.

Key responsibilities

In this role, you’ll

act as Regulatory Lead within cross-functional clinical trial teams across a portfolio of trials

manage regulatory submissions, including initial Combined Review, non-CTIMP, ARSAC, RFI responses, substantial modifications and post-approval notifications, working to tight deadlines

write, review and quality-check key clinical trial and regulatory documents

act as the key regulatory trial contact for colleagues, sponsors and the authorities

work collaboratively with colleagues and sponsors to find pragmatic and compliant solutions to regulatory questions

lead regulatory discussions with sponsors and cross-functional teams, providing clear advice on regulatory requirements, including the categorisation and assessment of trial modifications

contribute to continuous improvement of regulatory processes

support development and maintenance of regulatory SOPs and help ensure that records remain accurate and inspection-ready

share your regulatory expertise by training and mentoring colleagues in the Regulatory Affairs team

participate in sponsor audits and regulatory authority inspections

provide regulatory expertise to support business development opportunities and proposals

deepen your knowledge of UK clinical trial legislation and guidance relating to early-phase trials

Depending on business requirements and your experience, the role may also include line management responsibility for a small number of Regulatory Associates or Regulatory Officers.

Skills and experience required

Essential

A degree in a life science discipline, or equivalent relevant training and professional experience

Relevant Regulatory Affairs experience gained within a pharmaceutical, biotechnology, CRO or related clinical research environment

Thorough knowledge of the regulatory requirements and guidance applicable to UK clinical trials, particularly early-phase studies

Proven ability to manage Combined Review regulatory submissions and function as Regulatory Lead for clinical trials

Strong organisational skills, with the ability to manage multiple studies, submissions and priorities simultaneously to tight deadlines

Excellent written and verbal communication skills, with the confidence to communicate complex regulatory information clearly to sponsors and colleagues

Strong attention to detail and a commitment to quality

A collaborative approach and the ability to work effectively as part of cross-functional teams

Proven good judgement and problem-solving skills, including the ability to develop pragmatic solutions to regulatory questions and feedback

Desirable

Experience of submitting first-in-human trial applications

Experience of submitting ARSAC and Health Research Authority applications

Regulatory experience specifically in Phase I or Phase I/II clinical trials

Experience of supporting sponsor audits or regulatory authority inspections

Experience of contributing to continuous quality improvement activities or devising corrective and preventive action

Experience of managing, mentoring, coaching or training colleagues

Learning opportunities

This role offers the opportunity to

Develop specialist expertise in the UK regulations and guidance governing early-phase clinical development, learning from early-phase experts

Gain experience across a wide range of early phase trials designs, including first-in-human

Develop knowledge of CMC regulatory requirements for early phase trials through collaboration with our CMC regulatory team

Strengthen your knowledge of MHRA, Research Ethics Committee and ARSAC requirements

Develop your regulatory leadership and sponsor-facing skills

Gain exposure to audits, regulatory inspections and quality improvement initiatives

Mentor and develop colleagues across different levels of Regulatory Affairs.

Work closely with scientific, clinical and operational teams and gain broader insight into the end-to-end clinical trial process

Develop towards broader regulatory leadership and people management responsibilities.

Application

Requirements

When applying for a position with Quotient Sciences to be able to work in our organization 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 organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today.

Specifically we will not discriminate on the basis of race, color, 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.

Our Approach to AI in Recruitment

At Quotient Sciences, we use technology, including AI-enabled tools, to support parts of our recruitment process and help create an efficient, consistent, and inclusive candidate experience. Any use of AI is subject to human oversight, and hiring decisions are made by people, not technology.

While we embrace innovation, our recruitment process remains deeply human. Candidates who progress through our recruitment process are supported by a dedicated recruitment contact, and many of our selection processes include in-person interviews. We believe the best hiring decisions come from real conversations, giving candidates the opportunity to meet future colleagues, experience our culture and showcase their strengths beyond their application.

We recognize that candidates may choose to use AI tools when preparing applications. We encourage the responsible use of technology to support research, preparation, and drafting. However, applications should reflect your own skills, experiences, and perspectives. Throughout the recruitment process, we assess authenticity, critical thinking, technical capability, and the unique contribution you can bring to Quotient Sciences. Content generated entirely by AI may not provide an accurate representation of your suitability for the role.

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