Regulatory Specialist
hace 2 semanas
Precision for Medicine is a cutting-edge CRO that integrates clinical trial execution with scientific knowledge, laboratory expertise, and advanced data sciences. As we continue to grow, we are seeking a Regulatory and Start-Up Specialist to join our team in Spain. This position offers the opportunity to work fully from home. Key responsibilities include:
- Delivering site activation readiness within assigned countries/sites, anticipating and mitigating risks.
- Preparing Clinical Trial Application Forms, submission dossiers, and notifications for submission to regulatory bodies, such as the CA, EC, and other local authorities, in accordance with local requirements and timelines.
- Interacting with regulatory bodies and handling responses.
- Providing regular updates on submissions to the Start-Up Lead, Regulatory Lead, and Project Manager.
- Maintaining project plans, trackers, and regulatory intelligence tools.
- Partnering with site CRA to ensure alignment and secure site review and essential document collection.
- Customizing country/site-specific Patient Information Sheets and Informed Consent Forms.
- Translating and coordinating document translations.
- Maintaining communication with key functions, such as Feasibility, Clinical Operations, Project Management, and Site Contracts management.
- Collecting and maintaining site-level critical path data points, including local IRB, EC timelines, and site contracts.
- Participating in study budget negotiations and investigator contract execution.
Requirements include:
- Bachelor's degree in life sciences or a related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
- At least 1 year of experience as a Regulatory or Start-Up Specialist in a CRO or pharmaceutical/biotech industry or equivalent.
- Regulatory experience covering Belgium and the Netherlands.
- Strong communication and organizational skills.
- Fluency in English.
Precision for Medicine offers a dynamic work environment where employees' contributions are valued and nurtured, leading to positive change for the company.
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