Regulatory and Start Up Specialist

This is a fully remote position, open to applicants in Germany.

📋 Description

• Ensure timely and high-quality readiness for site activation across designated countries and sites.

• Prepare and submit Clinical Trial Application forms and dossiers to Competent Authorities, Ethics Committees, and other local entities.

• Engage with Competent Authorities and Ethics Committees, managing their feedback effectively.

• Provide regular submission updates to Start-Up Leads, Regulatory Leads, Project Managers, and various project teams.

• Maintain project plans, trackers, and tools for regulatory intelligence.

• Assist with study-specific start-up plans, IMP release requirements, and essential document review standards.

• Collaborate with designated site CRAs to ensure aligned communication and secure site commitments.

• Oversee and manage essential documents necessary for site activation and IMP release.

• Tailor Patient Information Sheets and Informed Consent Forms to meet country/site-specific requirements.

• Organize document translations as needed.

• Liaise with teams from Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts.

• Keep track of site-level critical-path data for regulatory, ethics committee, contract, and budget obligations.

• Assist in negotiations regarding study budgets and the execution of investigator contracts.

• Support outreach efforts for feasibility sites.

• Stay informed about local clinical trial laws and regulations, sharing insights within Precision for Medicine.

• Ensure audit and inspection readiness while organizing documents in the appropriate TMF.

• Provide assistance during Pre-Study Site Visits as required.

⛳️ Requirements

• Bachelor’s degree in life sciences or a related field, or a Registered Nurse (RN), or an equivalent combination of education, training, and experience.

• Minimum of 2 years of relevant experience.

• Prior experience as a Regulatory or Start-Up Specialist within a CRO or the pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies.

• Excellent communication and organizational skills.

• Proficiency in utilizing computerized information systems, electronic spreadsheets, word processing, and email.

• Fluency in both English and German.

• A qualification in Pharmacy or relevant work experience as a Pharmacist is highly advantageous.

• Preferred background includes relevant regulatory and site start-up experience.

• Experience in negotiating site contracts and budgets is preferred.

• Familiarity with milestone tracking tools/systems is preferred.

• An advanced degree in medical or life sciences, RAC certification, or a Master’s in Regulatory Science is preferred.

🏝️ Benefits

• Regular full-time employment.

• Flexible remote work arrangement.

• Commitment to equal opportunity employment.

• Reasonable accommodation support for applicants with disabilities.