Regulatory Manager / Senior Regulatory Manager (Oncology and Rare Disease)

Location: Remote, Romania

Company

hirify.global is a contract 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, including CTA/IND applications, amendments, annual reports, scientific advice requests, orphan designations, paediatric plans, and marketing applications.
• Develop and review documents for regulatory authorities and ethics committees to ensure compliance with applicable standards.
• Represent Global Regulatory Affairs in internal and external project meetings, client discussions, and business development activities.
• Lead regional or global projects, coordinate Regulatory Affairs Specialists, and maintain project plans, trackers, and regulatory intelligence tools.
• Provide ICH GCP guidance and training while supporting quality initiatives, 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 Manager level or 7 years for 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 results for regulatory strategy and positions.
• Professional proficiency in English is required; availability for domestic and international travel, including overnight stays, is required.

Culture & Benefits

• Remote work from Romania as part of a growing global organization.
• Opportunity to contribute to clinical development programs for cancer and rare disease therapies.
• Collaborative work with internal teams, external clients, regulatory authorities, ethics committees, and investigative staff.
• Support for continuous improvement, professional development, and employee contributions.