Regulatory Manager / Senior Regulatory Manager (Clinical Trials)

Location: Remote, Serbia; domestic and international travel with overnight stays may be required.

Company

hirify.global is a contract research organization integrating clinical trial execution, scientific expertise, laboratory capabilities, and advanced data sciences for life sciences programs, 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, scientific advice procedures, orphan designations, paediatric plans, annual reports, and marketing applications.
• Develop and review regulatory documents for compliance with applicable regulations and guidance.
• Represent Global Regulatory Affairs in internal and external project, client, and business development meetings.
• Lead regional or global project activities, maintain project plans and regulatory intelligence tools, and coordinate Regulatory Affairs Specialists against submission targets.
• Provide ICH GCP guidance and training, support quality initiatives, and contribute to regulatory strategy and timeline development.

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 regulations for at least one major region, including the EU or US.
• Ability to interpret clinical and pre-clinical study results and apply them to regulatory strategy.
• Effective spoken and written English communication and availability for domestic and international travel are required.

Culture & Benefits

• Remote role within a growing global organization.
• Opportunity to contribute to programs involving cancer and rare disease therapies.
• Ideas and input are valued as part of continuous improvement and organizational change.
• Work includes collaboration with internal teams, external clients, investigative staff, and regulatory stakeholders.