Regulatory - Regulatory Affairs Manager

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.