Regulatory and Start-Up Specialist
hace 4 semanas
Regulatory and Start-Up Specialist
Precision Medicine Group is a unique Contract Research Organization (CRO) that combines cutting-edge technologies, expertise, and operational scale to accelerate the development of life-changing therapies. We are seeking a highly skilled Regulatory and Start-Up Specialist to join our team in Spain, working fully remotely. This role will be responsible for ensuring the timely and quality delivery of site activation readiness within assigned countries/sites, identifying and mitigating potential risks. Key responsibilities include preparing Clinical Trial Application Forms, submission dossiers, and interacting with regulatory authorities. The successful candidate will provide regular updates to the Start-Up Lead and Project Manager, maintain project plans and trackers, and facilitate the translation and coordination of documents. This is an exciting opportunity to work with a dynamic team and contribute to the success of our organization.
Key Responsibilities:
• Prepare Clinical Trial Application Forms and submission dossiers for regulatory authorities
• Interact with regulatory authorities and handle responses
• Provide regular updates to the Start-Up Lead and Project Manager
• Maintain project plans and trackers
• Facilitate the translation and coordination of documents
Requirements:
• Strong knowledge of regulatory requirements and clinical trial regulations
• Excellent communication and project management skills
• Ability to work independently and as part of a team
• Proficiency in Microsoft Office and regulatory intelligence tools
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