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Specialist, Study Start Up – Regulatory Affairs
ERGOMEDStudy Start-Up and Regulatory Specialist supporting rare disease and oncology clinical trials at Ergomed, a specialist CRO. Coordinating regulatory submissions, site activation, agreements, and essential trial documentation.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing study start-up activities, regulatory submissions, and compliance with ICH GCP and national regulations. Proficient in coordinating essential documents and liaising with project teams, authorities, and vendors to ensure timely deliverables.
Highest-signal resume keywords
Study Start-Up ManagementRegulatory SubmissionsICH GCP ComplianceDocument Review and TrackingPharmaceutical Industry Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory DeliverablesEssential Document ManagementClinical Site AgreementsProject Tracker CompletionStudy Portal Management
Soft Skills
Written CommunicationVerbal Communication
Tools & Technologies
Study PortalTMF Filing
Industry Keywords
Pharmaceutical IndustryCRO IndustryNational RegulationsSite ActivationInvestigational Product Release
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Complete study start-up and regulatory deliverables according to the SSU RA management plan
- Liaise with SSU/regulatory project teams, authorities, vendors, and investigative sites
- Independently manage low-complexity study start-up activities under senior guidance
- Prepare, collect, review, and submit regulatory information to national authorities and ECs/IRBs
- Collect, review, and track essential documents for site initiation and activation
- Investigate incomplete, inaccurate, or missing documents
- Prepare study team reports and updates on essential document status
- Draft, negotiate, finalize, and execute clinical site and ancillary agreements and amendments
- Conduct site outreach and manage confidential disclosure agreements
- Coordinate documents and activities leading to investigational product release, site activation, and site initiation
- Review labels, patient information sheets, diary cards, insurance, and related documentation for ICH GCP and country-specific compliance
- Arrange and review translations of essential documents
- Contribute to regulatory and study start-up strategies and plans
- Complete project trackers, study portal and TMF filing, and submission dossier QC
- Ensure deliverables and essential document submissions meet project timelines, expectations, SOPs, and study-specific requirements
Requirements
What you’ll need- Graduate degree in Chemistry or Life Sciences, Pharmacy, MD, or equivalent combination of education and experience
- Previous experience within the pharmaceutical or CRO industry
- Good knowledge of ICH GCP and national regulations for territories of competency
- Good written and verbal communication skills
- Proficiency in English, written and verbal
Benefits
Comp & perks- Remote work
- Collaborative, international team
- Career growth opportunities
- Work-life balance
- Supportive culture
- Opportunity to work with experts in clinical research, pharmacovigilance, and quality consulting