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 in assigned countries/sites while identifying and mitigating potential risks.

• Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, and other local organizations.

• Engage with Competent Authorities and Ethics Committees to manage responses effectively.

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

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

• Assist with study-specific start-up plans, IMP release requirements, and review criteria for essential documents.

• Coordinate with assigned site CRAs to ensure effective communication and secure site collaboration.

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

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

• Oversee document translations.

• Liaise with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams regarding ongoing status and deliverables.

• Maintain critical path data at the site level for site activation, including timelines for authorities and ethics committees, contracts, and budget negotiations.

• Assist in budget negotiations and the execution of investigator contracts.

• Support outreach for feasibility sites.

• Keep updated on local clinical trial laws and regulations, sharing regulatory knowledge within PFM.

• Ensure audit and inspection readiness, filing documents in accordance with TMF plans.

• Provide support for Pre-Study Site Visits as needed.

• Handle regulatory submissions and site contract and budget negotiations in Germany, Austria, and Switzerland.

⛳️ Requirements

• Bachelor’s degree in life sciences or a related field, or 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 in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies.

• Proficiency with computerized information systems, including electronic spreadsheets, word processing, and email tools.

• Fluency in both English and German.

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

• Excellent communication and organizational skills.

• Relevant experience in regulatory and site start-up preferred.

• Experience in site contract and budget negotiation 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.

• Remote work arrangement.

• Equal opportunity employment.

• Reasonable accommodation support for applicants with disabilities.