Research Regulatory Operations Manager (Newborn...

@ Genomics England

Company Description

Genomics England partners with the NHS to provide whole genome sequencing diagnostics. We also equip researchers to find the causes of disease and develop new treatments – with patients and participants at the heart of it all. Our mission is to refine, scale, and evolve genomic healthcare and research.

Job Description

We are seeking a Research Regulatory Operations Manager (Newborns) for a 12-month fixed-term contract. You will join our Ethics team managing the research regulatory processes for the Generation Study and related projects, in support of the strategic efforts for Newborns.

Key Responsibilities

• Define and implement research regulatory strategy alongside the Ethics Lead (Newborns).
• Integrate regulatory amendments and submissions for the Generation Study and associated sub-studies.
• Prepare and collate submissions to the Health Research Authority (HRA) according to IRAS and NHS R&D requirements.
• Handle amendment notifications, track responses, and escalate issues as needed.
• Oversee regulatory documentation and updates for local study approval.
• Collaborate with Mobilisation and Performance Teams to manage protocol deviations and notifiable events.
• Support study set-up, maintenance, and close-down with quality assurance focus.
• Act as the regulatory liaison among cross-functional teams.

Skills and Experience

• Experience with Health Regulatory Authority (HRA) processes.
• Proficiency in IRAS forms handling and submissions.
• Knowledge of legal and ethical research governance, data protection, and consent.
• Exceptional attention to detail and data integrity.
• Strong organization and administrative management skills.
• Excellent communication and collaboration abilities.

Additional Information & Benefits

Salary from: £50,750. Must travel 2-3 days per month to the London office. Benefits include generous leave, flexible working arrangements, competitive pension and financial benefits, robust learning and development support, employee recognition, and health & wellbeing initiatives.

Work Arrangement & Onboarding

Operates under a blended working model with a minimum office presence in London. Onboarding includes standard background checks (DBS).

Key skills/competency

• regulatory
• operations
• research
• ethics
• HRA
• IRAS
• compliance
• documentation
• communication
• project management