Regulatory - Regulatory Affairs Manager

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.

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.