[Zv347] - Study Start-Up / Regulatory Associate

We have an open position for a STUDY START UP/REGULATORY ASSOCIATE with at least 1-3 years of experience to join our Regulatory unit within the clinical operations department.
RESPONSIBILITIES: Providing the list of documents necessary for initial submissions to CA and EC to request authorization.
Ensuring the documentation prepared for submission to ECs and CA is in compliance with Spanish regulations.
Collection of essential documents necessary for ECs approval from each selected site.
Ensuring the final budget agreed with PI and other Departments (if applicable) is included in the draft CTA to be submitted to ECs.
Preparing ECs and CA submission packages in line with local requirements.
Performing submissions through the OsSC and according to Spanish regulations.
Submission of answers to ECs and CA queries, when applicable.
Contract and budget negotiation with sites.
MINIMUM REQUIREMENTS: At least 1-3 years of experience in Regulatory/start-up in 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 EC/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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