Regulatory Manager / Senior Regulatory Manager (Clinical Trials)

Location: Remote, Poland; availability for domestic and international travel, including overnight stays, is required.

Salary: 190,200–285,400 PLN gross per annum, plus eligibility for a discretionary annual bonus.

Company

hirify.global is a contract research organization integrating clinical trial execution, scientific expertise, laboratory capabilities, and 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, scientific advice procedures, orphan designations, paediatric plans, annual reports, and marketing applications.
• Develop and review submission documents for regulatory compliance and represent Global Regulatory Affairs in project, client, and business development meetings.
• Lead regional or global regulatory projects and coordinate Regulatory Affairs Specialists to achieve submission targets.
• Maintain project plans, trackers, regulatory intelligence tools, quality initiatives, and regulatory timelines.
• Provide ICH GCP guidance, training, regulatory intelligence, and professional development support to colleagues and clients.

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 experience leading 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, develop regulatory positions, manage multiple priorities, and work independently and collaboratively.
• Professional English communication skills are required, including formal presentations to colleagues, investigators, and clients.

Nice to have

• Experience in oncology or rare disease programs.
• Knowledge of specialised regulatory procedures, including scientific advice, orphan designations, paediatric planning, and accelerated procedures.
• Experience developing regulatory strategy and timelines for new study opportunities.

Culture & Benefits

• Remote work from Poland within a growing global organization.
• Private medical insurance, MultiSport Card, life insurance, and pension benefits.
• Home working allowance and vacation benefits.
• Discretionary annual bonus and opportunities to contribute ideas and continuous improvement initiatives.