Regulatory Manager / Senior Regulatory Manager (Oncology)

Location: Remote, United Kingdom

Company

hirify.global is a clinical research organization integrating clinical trial execution, scientific expertise, laboratory capabilities, and advanced data sciences, with a focus on oncology and rare disease.

What you will do

• Provide regulatory strategy and development guidance throughout the clinical development lifecycle.
• Compile, coordinate, and review submissions to Regulatory Authorities and Ethics Committees, including CTA/IND applications, amendments, annual reports, scientific advice procedures, orphan designations, paediatric planning, and marketing applications.
• Develop and review submission documents to ensure compliance with applicable regulatory standards.
• Represent Global Regulatory Affairs at internal, client, project team, and business development meetings.
• Lead regional or global regulatory projects, coordinate Regulatory Affairs Specialists, and maintain project plans, trackers, and regulatory intelligence tools.
• Provide ICH GCP guidance, training, and regulatory input to internal and external stakeholders.

Requirements

• Bachelor’s degree or equivalent experience, ideally in a scientific or healthcare discipline.
• At least 5 years of regulatory experience for the Manager level or 7 years for the Senior Manager level.
• Regulatory affairs experience in a CRO or pharmaceutical company, including leadership of clinical submissions.
• Knowledge of drug development, clinical trial methodology, regulatory milestones, and applicable pharmaceutical development regulations.
• Specialized regulatory experience in at least one major region, including the EU or US, and experience with INDs/CTAs, amendments, scientific advice, and post-approval submissions.
• Professional written and verbal English, strong presentation skills, and availability for domestic and international travel, including overnight stays.

Culture & Benefits

• Remote work from the United Kingdom within a growing global organization.
• Opportunity to contribute to clinical programs supporting cancer therapies and rare disease research.
• Collaborative work with internal teams, external clients, regulatory authorities, and Ethics Committees.
• Support for professional development, continuous improvement, and expansion of regulatory knowledge.
• Employee contributions and ideas are encouraged and valued.