Regulatory and Start Up Specialist
Precision Medicine Group
full-time
Posted on:
Location Type: Remote
Location: Italy
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Job Level
About the role
- Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
- Preparation of Clinical Trial Application Forms as well as preparation of submission dossier for submission to Competent Authorities, Ethics Committees, and other applicable local bodies.
- Interaction with CA/EC for study purposes and handling responses to the CA/EC.
- Maintenance of project plans, project trackers and regulatory intelligence tools.
Requirements
- Bachelor’s degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
- A qualification in Pharmacy/work experience as a Pharmacist would be highly beneficial.
- 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/biotech industry
Benefits
- Health insurance
- Flexible work arrangements
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Clinical Trial Application Formssubmission dossier preparationproject plans maintenanceproject trackersregulatory intelligence tools
Soft Skills
timelinessquality assurancerisk mitigationinteraction with authorities
Certifications
Bachelor’s degree in life sciencesRegistered Nurse (RN)qualification in Pharmacy