7 days left
- Experience Level
- Experienced (non-manager)
We have an opening position for a REGULATORY ASSOCIATE with at least 2-3 years of experience to join our Regulatory unit within the clinical operation department.
The Regulatory Associate is responsible for routine regulatory support and for providing guidance to support timely filings and maintenance of assigned programs. Compile and maintain regulatory documentation databases or systems and coordinate efforts associated with the preparation of regulatory documents or submissions.
REQUIRED PROFILE: We are looking for candidates with the following skills
- Science Degree with at least 2-3 years of experience in Regulatory/start-up on clinical trials. Sound knowledge of GCPs/ICH and international/local regulations Updated knowledge of national/international regulations relative to clinical Trial Start Up Procedures.
- Previous experience in/with
- Preparation of the request for clinical trials authorization
- Competent Authority (CA) and REC/HRA and R&D submissions;
- Contract and budget negotiation with sites as needed
- Fluent in English Team Management Good knowledge of Office (Word, Excel and Powerpoint)
- Above all, we appreciate motivation, excellent team player, and independent and well-structured way of working
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