Regulatory Affairs Specialist, Danish Speaker
Worldwide Clinical Trials
contract
Posted on:
Location Type: Remote
Location: Remote • 🇩🇰 Denmark
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- Liaise with SAR colleagues to plan, organize, compile, progress, track and submit regulatory submissions on a timely basis
- Act as a contact point for translation review of submissions documents
- Provide local QC of submission dossiers prior to dispatch
- Communicate status and action plans concerning submissions
Requirements
- Degree with a major concentration in medical, biological, physical, health, pharmacy or other related science
- Minimum three years of experience in clinical research, in site activation and/or regulatory-related function within a CRO
- Strong experience in the regulatory process in Denmark, specifically under the EU-CTR
- Good knowledge of ICH GCP, relevant clinical research conduct guidance and country regulations
- Fluency in Danish; working knowledge of English
Benefits
- Diverse and inclusive work environment
- Hands-on leadership
- Supportive teams
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory submissionsclinical researchsite activationregulatory processICH GCPclinical research conduct guidancecountry regulations
Soft skills
communicationorganizationplanningtrackingquality control
Certifications
degree in medical sciencedegree in biological sciencedegree in physical sciencedegree in health sciencedegree in pharmacy