Regulatory Affairs Specialist – Contractor
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
- May act as a contact point for translation review of submissions documents such as application, synopsis, ICF, labels etc.
- Where required provide local QC of submission dossiers prior to dispatch
- Effectively communicate to the SAR Lead and relevant project team members the status and action plans concerning submissions
- Identify risks and generate mitigation strategies
- Maintain country specific patient information sheet and consent form customization text
- Maintain country specific drug labeling information
- Stay informed of changing regulatory legislative requirements and maintain regulatory intelligence database
- Advise the SAR project team about appropriate regulatory strategies
- Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc. to comply with ICH GCP & country specific requirements
Requirements
- Degree with a major concentration in medical, biological, physical, health, pharmacy or other related science
- Minimum three year of experience in clinical research, in site activation and/or regulatory-related function within a CRO
- Candidates must have strong experience in the regulatory process in Denmark, specifically under the EU-CTR, to be considered for this role.
- Good knowledge of ICH GCP, relevant clinical research conduct guidance and country regulations
- Fluency in the Danish language is a mandatory requirement; working knowledge of English
Benefits
- Health insurance
- Retirement plans
- Flexible work arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory submissionsquality control (QC)regulatory strategiesclinical researchsite activationICH GCPEU-CTRregulatory intelligence databaserisk identificationmitigation strategies
Soft skills
communicationorganizationplanningcollaborationproblem-solving
Certifications
degree in medical sciencedegree in biological sciencedegree in physical sciencedegree in health sciencedegree in pharmacy