Regulatory and Start Up Specialist (Germany)

Location: Home based in Germany; Frankfurt, Hesse, Germany

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Coordinate country-level site activation and start-up activities in line with applicable regulations, SOPs, work instructions, and project requirements.
• Serve as the single point of contact for investigative sites, Site Activation Managers, project management, and other departments.
• Prepare, review, distribute, track, and follow up on regulatory, ethics, informed consent, investigator package, and contractual documents.
• Maintain accurate study information in internal systems, databases, and tracking tools.
• Support project planning, timelines, monitoring measures, contingency plans, and site performance reviews.
• Perform document quality control and provide local expertise to project teams and sponsors.

Requirements

• German language fluency is required.
• Experience with local regulatory submissions in Germany.
• Experience with contract negotiations.
• Knowledge of clinical study start-up, site activation, regulatory, and ethics documentation.
• Ability to work according to SOPs, work instructions, regulations, project timelines, and quality requirements.

Culture & Benefits

• Home-based working arrangement in Germany.
• Full-time employment.
• Work within global clinical research and healthcare intelligence operations.