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regulatory affairs tmf ich-gcp regulatory compliance site start-up📋 Description
- Deliver site activation readiness within assigned country/sites on time.
- Prepare Clinical Trial Applications and submission dossiers for authorities.
- Interact with CA/EC for study purposes and respond to inquiries.
- Provide updates on submissions to Start Up Lead, Regulatory Lead, and PM.
- Maintain project plans and regulatory trackers for assigned responsibilities.
- Support start-up plans, IMP release needs, and essential document reviews.
🎯 Requirements
- Bachelor’s degree in life sciences or RN or equivalent.
- 1+ year Regulatory or Start-Up specialist experience in CRO/pharma.
- Fluent in English.
- Strong communication and organizational skills.
- Experience with milestone tracking tools/systems.
- Advanced degree in medical or life sciences or RAC certification (preferred).
🎁 Benefits
- Growing organization focused on cancer therapies and rare diseases.
- Collaborative culture where your ideas are valued.
- Cross-functional teamwork with Regulatory, Start-Up, and PM.
- Equal Opportunity Employer supporting diversity.
- Impactful role helping bring clinical trials to patients.
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