Regulatory and Start-Up Specialist
hace 3 semanas
Job Summary
Precision for Medicine 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.
Key Responsibilities
- Ensure timely and high-quality delivery of site activation readiness within assigned countries/sites, identifying and mitigating potential risks.
- Prepare and submit Clinical Trial Application Forms and submission dossiers to regulatory authorities, adhering to local requirements and timelines.
- Collaborate with regulatory authorities, handling responses and providing regular updates to the Start-Up Lead and Project Manager.
- Maintain project plans, trackers, and regulatory intelligence tools, keeping Regulatory Leadership informed.
- Develop study-specific start-up plans, IMP release requirements, and essential document review criteria.
- Partner with site CRAs to ensure alignment, manage document collection, and customize country/site-specific patient information sheets and informed consent forms.
- Coordinate translations and maintain communication with key functions, including Feasibility, Clinical Operations, Project Management, and Site Contracts management.
- Act as a subject matter expert for site-level critical path data points, including Competent Authority, local IRB/Ethics Committee timelines, site contracts, and budget negotiation requirements.
Requirements
- Strong knowledge of regulatory affairs, clinical trials, and start-up processes.
- Excellent communication and project management skills.
- Ability to work independently and collaboratively as part of a global team.
- Fluency in English and proficiency in Spanish.
About Precision for Medicine
We are a dynamic organization that values innovation, collaboration, and excellence. If you are a motivated and detail-oriented professional with a passion for regulatory affairs and start-up processes, we encourage you to apply for this exciting opportunity.
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