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Precision for Medicine is a global Clinical Research Organization specializing in precision medicine, combining novel clinical trial designs, operational expertise, biomarker analytics, and a focus on rare diseases and oncology.
You will join as a Regulatory and Start-Up Specialist based in Germany, with responsibility for regulatory submissions and site contract/budget negotiations across Germany, Austria, and Switzerland. This role bridges regulatory compliance and operational site activation, requiring both technical regulatory knowledge and commercial negotiation skills.
Key Responsibilities:
- Prepare and submit Clinical Trial Application Forms and regulatory dossiers (initial and amendments) to Competent Authorities, Ethics Committees, and local bodies per local requirements and ICH-GCP principles
- Manage interactions with regulatory and ethics bodies, handling submissions and responses
- Provide regular updates to Start-Up and Regulatory Leads on CA/EC submission status
- Maintain project plans, trackers, and regulatory intelligence tools
- Develop study-specific start-up plans, IMP release requirements, and essential document review criteria
- Partner with site Clinical Research Associates to ensure alignment and secure site activation
- Review and manage collection of essential documents for site activation and IMP release
- Customize country/site-specific Patient Information Sheets and Informed Consent Forms
- Coordinate document translations
- Maintain communication with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams
- Act as subject matter expert for site-level critical path data (CA/EC timelines, site contracts, budget negotiations)
- Participate in and support negotiation of study budgets and investigator contracts under Site Contract Management direction
- Support feasibility team in site outreach and investigator interest assessment
- Maintain current knowledge of local clinical trial laws and regulations; distribute expertise across PFM
- Maintain audit/inspection readiness and file documents per TMF plans
- May support clinical team in Pre-Study Site Visits
Requirements:
Minimum: Bachelor's degree in life sciences or related field (scientific or healthcare discipline), or Registered Nurse (RN), or equivalent education/training/experience. At least 2 years of relevant experience. Pharmacy qualification or pharmacist experience highly beneficial.
Other Required: Previous experience as Regulatory or Start-Up Specialist in a CRO or pharmaceutical/biotech industry, or equivalent demonstrated competencies. Strong communication and organizational skills. Experience with computerized information systems, electronic spreadsheets, word processing, and email. Fluency in English and German.
Preferred: Relevant regulatory and site start-up experience (feasibility, contract negotiations, CA/EC/IRB submissions). Site contract and budget negotiation experience. Experience with milestone tracking tools/systems. Ability to prioritize workload to meet deadlines. Advanced degree (MD, PhD, PharmD) or RAC certification or Master's in Regulatory Science.
