Related skills
regulatory affairs contract negotiations tmf ich-gcp site start-up📋 Description
- Deliver site activation readiness on time and in quality.
- Prepare CTA forms and submission dossiers for authorities.
- Interact with CA/EC and handle responses.
- Provide updates to Start Up Lead, Regulatory Lead, and PM.
- Maintain project plans, trackers, and regulatory tools.
- Prepare/start-up plans, IMP release requirements, docs review.
🎯 Requirements
- Bachelor’s degree in life sciences or RN.
- Pharmacy degree or Pharmacist experience is beneficial.
- 1+ year regulatory or start-up experience in CRO/pharma.
- Strong communication and organizational skills.
- Fluency in English.
- Experience with milestone tracking tools/systems.
🎁 Benefits
- Equal Opportunity Employer.
- Disability accommodations available.
- Privacy policy and CA privacy notice.
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