Related skills
regulatory submissions tmf ich-gcp irb/ec site activation📋 Description
- Responsible for timely site activation readiness and risk mitigation.
- Prepare Clinical Trial Application and submission dossiers per local requirements.
- Manage CA/EC submissions, responses, and regulatory timelines.
- Maintain project plans, trackers, and regulatory intelligence tools.
- Customize country/site specific Patient Information Sheet and Informed Consent Form.
- Ensure TMF readiness and document filing per TMF plan.
🎯 Requirements
- Bachelor's degree in life sciences or RN or equivalent.
- 1+ year Regulatory/Start-Up in CRO or pharma.
- English fluency; strong communication and organizational skills.
- Knowledge of CA/EC/IRB submissions and ICH-GCP.
- Experience with milestone tracking tools.
- Advanced degree in medical or life sciences or RAC certification preferred.
🎁 Benefits
- Equal Opportunity Employer; diverse and inclusive.
- Accommodations available for applicants with disabilities.
- Opportunities to impact cancer therapies and growth.
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