Regulatory and Start Up Specialist

Precision Medicine Group

. Deliver timely and high-quality site activation readiness for assigned countries and sites .

Posted 10/23/2026full-timeRemote • GermanyJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory submissions, site activation processes, and compliance with local clinical trial laws. Proficient in managing project plans and maintaining audit readiness while effectively communicating with cross-functional teams.

Highest-signal resume keywords

Regulatory SubmissionsSite ActivationClinical Trial Application PreparationBudget NegotiationFluency in English and German

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory ExperienceSite Start-Up ExperienceDocument ManagementPatient Information Sheet CustomizationInformed Consent Form Customization

Soft Skills

Strong Communication SkillsOrganizational Skills

Tools & Technologies

Computerized Information SystemsElectronic SpreadsheetsWord ProcessingMilestone Tracking Tools

Certifications & Qualifications

RAC CertificationBachelor’s Degree in Life SciencesQualification in Pharmacy

Industry Keywords

CROPharmaceutical IndustryBiotech IndustryClinical OperationsEthics Committees

About the role

Key responsibilities & impact

Deliver timely and high-quality site activation readiness for assigned countries and sites
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, 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 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
Maintain site-level critical-path data for regulatory, ethics committee, contract, and budget requirements
Support study budget negotiations and investigator contract execution
Support feasibility site outreach
Maintain knowledge of local clinical trial laws and regulations and share knowledge within Precision for Medicine
Maintain audit and inspection readiness and file documents in the relevant TMF
Support Pre-Study Site Visits when required

Requirements

What you’ll need

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
Strong communication and organizational skills
Experience using 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
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

Comp & perks

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