Principal RASSU Specialist

This is a fully remote position, open to applicants in Portugal, +2 more countries.

📋 Description

• Support and guide project teams regarding regulatory requirements for clinical trials.

• Conduct compliance assessments specific to each country, document results, and inform Project Managers.

• Review and modify study documents in accordance with country and site regulations.

• Manage or supervise submissions to IRB/IEC and other regulatory entities on behalf of sponsors and/or sites.

• Receive, evaluate, and perform quality checks on study documentation from sites.

• Collaborate with site staff, CPCs, CRAs, and PMs to address documentation challenges.

• Assemble and ensure quality control of regulatory documents and submission packages.

• Modify, prepare, validate, and file site-specific Informed Consent Forms.

• Prepare or ensure quality control for Clinical Trial Application forms, including CTA and XML formats.

• Communicate with Sponsors and transmit regulatory documentation as required.

• Address deficiency letters from sponsors and study PMs or support sites in formulating responses.

• Compile and evaluate Regulatory Packages for drug release processes.

• Deliver accurate periodic regulatory status updates and participate in project meetings.

• Upload and manage complete study documentation within study start-up modules, trackers, and TMF systems.

• Conduct reviews, reconciliations, closures, and archiving of study documentation.

• Independently prepare for audits and inspections conducted by Sponsors or Agencies.

• Perform quality control and quality assurance on regulatory documents and reports.

• Supervise the translation of regulatory documents when necessary.

• Represent the Regulatory Department during capabilities and bid defense presentations.

• Train and mentor junior Regulatory and other functional staff.

• Develop Standard Operating Procedures (SOPs) and oversee updates and improvements to processes.

• Manage site budgets and contracts based on country/region requirements.

⛳️ Requirements

• Associate’s or bachelor’s degree in a health-related field such as nursing, pharmacy, or health science, or equivalent relevant experience.

• At least 8–10 years of pertinent pharmaceutical or CRO regulatory experience.

• Proficient in spoken and written English.

• Capability to support regulatory requirements for clinical trials across relevant countries and sites.

• Understanding of country-specific regulatory mandates.

• Proficient in conducting compliance assessments and documenting findings.

• Experience with submissions to IRB/IEC and/or other regulatory bodies.

• Proficient in reviewing, modifying, compiling, quality-checking, filing, and archiving regulatory documentation.

• Familiarity with Clinical Trial Application forms (e.g., CTA, XML).

• Ability to respond to deficiency letters effectively.

• Preparedness for audits and inspections by Sponsors or Agencies.

• Competence in performing quality control and quality assurance on regulatory documents and reports.

• Capability to oversee translations of regulatory documents.

• Experience in training and mentoring less experienced personnel.

• English-language application is mandatory.

🏝️ Benefits

• Structured mentoring program.

• Leadership development courses.

• Dedicated training department.

• Ongoing educational support.

• Hybrid work opportunities.

• CTI Cares community and global philanthropic initiatives.

• Support for work-life balance.