Principal RASSU Specialist

🔥 0 minutes ago

🌐 Portugal, Spain, +1 more countries – Remote

🇵🇹 Portugal – Remote 🇪🇸 Spain – Remote 🇵🇱 Poland – Remote

⏰ Full Time

🔴 Lead

✨ Principal

👻 Ghost score 10%

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CTI Clinical Trial and Consulting Services

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1999

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

CTI Clinical Trial and Consulting Services is a full-service contract research organization (CRO) that provides clinical trial execution, regulatory strategy, lab and bioanalytical services, real-world evidence generation, and research center management to biotech and pharmaceutical sponsors. With expertise across Phase I–IV studies and complex therapeutic areas (including rare diseases, cell and gene therapy, oncology, neurology, and transplantation), CTI supports study design, site management, patient recruitment, monitoring, safety/pharmacovigilance, biometrics, and quality assurance. Headquartered in Covington, KY, the company emphasizes integrated, patient-centric approaches and global regulatory guidance to accelerate development and bring therapies to patients.

📋 Description

• Assist and advise project teams on regulatory requirements for clinical studies • Perform country-specific compliance assessments, document findings, and notify Project Managers • Review and adapt study documents according to country and site requirements • Perform or oversee IRB/IEC and other Regulatory Bodies submissions for sponsors and/or sites • Receive, process, and quality-check study documentation from sites • Coordinate with site personnel, CPCs, CRAs, and PMs to resolve documentation issues • Compile and QC regulatory documentation and submission packages • Adapt, prepare, quality-check, and file site-specific Informed Consent Forms • Prepare or QC Clinical Trial Application forms, including CTA and XML • Interact with Sponsors and forward regulatory documentation when requested • Respond to deficiency letters with sponsors and study PMs or assist sites with responses • Compile and assess Regulatory Packages for drug release • Provide accurate periodic regulatory status reports and attend project meetings • Upload and process complete study documentation in study start-up modules, trackers, and TMF systems • Perform review, reconciliation, close-out, and archiving of study documentation • Independently prepare for Sponsor or Agency audits and inspections • Perform QC and QA of regulatory documents and reports • Oversee translation of regulatory documents when needed • Represent the Regulatory Department in capabilities and bid defense presentations • Train and mentor less experienced Regulatory and other functional staff • Develop SOPs and monitor process updates and improvements • Manage site budgets and site contracts depending on countries/regions

🎯 Requirements

• Associate’s or bachelor’s degree in an allied health field such as nursing, pharmacy, or health science, or equivalent relevant experience • Minimum of 8–10 years of relevant pharmaceutical or CRO Regulatory experience • Fluent spoken and written English • Ability to support regulatory requirements for clinical studies across applicable countries and sites • Knowledge of country-specific regulatory requirements • Ability to perform compliance assessments and document findings • Experience with IRB/IEC and/or other Regulatory Bodies submissions • Experience reviewing, adapting, compiling, quality-checking, filing, and archiving regulatory documentation • Experience with Clinical Trial Application forms (e.g. CTA, XML) • Ability to respond to deficiency letters • Ability to prepare for Sponsor or Agency audits and inspections • Ability to perform QC and QA of regulatory documents and reports • Ability to oversee regulatory document translations • Ability to train and mentor less experienced staff • English-language application required

🏖️ Benefits

• Structured mentoring program • Leadership development courses • Dedicated training department • Ongoing education support • Hybrid work opportunities • CTI Cares community and global giving opportunities • Work-life balance support