Related skills
regulatory submissions tmf ich-gcp site activation clinical trial applications📋 Description
- Deliver site activation readiness for assigned country/sites on time and with quality.
- Prepare Clinical Trial Applications and submission dossiers for authorities/ethics committees.
- Interact with CA/EC for study purposes and respond to submissions.
- Provide regular updates to Start Up Lead, Regulatory Lead, and Project Manager.
- Maintain project plans, trackers, and regulatory intelligence tools for assigned duties.
- Customize country/site Patient Information Sheet and Informed Consent Form.
🎯 Requirements
- Bachelor's degree in life sciences or RN; pharmacy background beneficial.
- Regulatory/start-up experience in CRO or pharma.
- Knowledge of CA/EC submissions, ICH-GCP, and TMF basics.
- Strong communication and organizational skills; MS Office proficiency.
- Fluent in English.
- Preferred: advanced life sciences degree or RAC; milestone tracking experience.
🎁 Benefits
- Grow with a company serving groundbreaking cancer therapies.
- Equal opportunity employer with an inclusive culture.
- Collaborative environment where your input matters.
- Remote work options and flexible collaboration.
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