Regulatory and Start Up Specialist

🔥 1 hour ago

🇩🇪 Germany – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Deliver timely and high-quality site activation readiness for assigned countries/sites and foresee and mitigate risks • Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies • Interact with Competent Authorities and Ethics Committees and handle responses • Provide submission updates to Start Up Leads, Regulatory Leads, Project Managers, and project teams • Maintain project plans, project trackers, and regulatory intelligence tools • Support study-specific start-up plans, IMP release requirements, and essential document review criteria • Coordinate with assigned site CRAs to align communication and secure sites • Review and manage essential documents required for site activation and IMP release • Customize country/site-specific Patient Information Sheets and Informed Consent Forms • Coordinate document translations • Communicate with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams regarding status and deliverables • Maintain site-level critical path data for site activation, including authority and ethics committee timelines, contracts, and budget negotiation requirements • Support study budget negotiations and execution of investigator contracts • Support feasibility site outreach • Maintain knowledge of local clinical trial laws and regulations and distribute regulatory knowledge within PFM • Maintain audit and inspection readiness and file documents according to TMF plans • Support Pre-Study Site Visits when required • Cover regulatory submissions and site contract and budget negotiation in Germany, Austria, and Switzerland

🎯 Requirements

• Bachelor’s degree in life sciences or related field, or Registered Nurse (RN), or equivalent combination of education, training, and experience • At least 2 years of relevant experience • Previous experience as a Regulatory or Start Up specialist in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies • Experience with computerized information systems, electronic spreadsheets, word processing, and electronic mail • Fluency in English and German • Qualification in Pharmacy or work experience as a Pharmacist highly beneficial • Strong communication and organizational skills • Relevant regulatory and site start-up experience preferred • Experience in site contract and budget negotiation preferred • Experience using milestone tracking tools/systems preferred • Advanced degree in medical or life sciences, RAC certification, or Master’s in Regulatory Science preferred

🏖️ Benefits

• Regular full-time employment • Remote work arrangement • Equal opportunity employment • Reasonable accommodation support for applicants with disabilities