Principal RASSU Specialist

CTI Clinical Trial and Consulting Services; Lisboa; Presencial; EUR 70 000 - 110 000; Tempo integral

Resumo da oferta

CTI Clinical Trial and Consulting Services in Portugal is seeking a Global RASSU Lead to serve as the regulatory SME for clinical trial regulatory requirements. You will align with CTI and sponsor SOPs, ICH/GCP, and applicable regulations, while supporting regulatory document oversight, eTMF/TMF review, audits, training, and mentoring across regional and country teams.

The role oversees submission strategy, regulatory tracking, and green-light processes from study start-up to close-out.

Qualificações

• Bachelor’s degree in allied health field or equivalent.
• 8+ years in research, regulatory, pharmaceutical, site, or CRO.
• Strong knowledge of EU CTR, CTIS, MHRA, Ethics Committee/IRB/IEC processes and country regulations.
• Excellent understanding of ICH/GCP, SOPs, GDPR, and trial documentation standards.
• Experience with regulatory study start-up activities, including document preparation and regulatory tracking.
• Experience supporting or overseeing global and regional clinical trial submissions.
• Excellent written and verbal communication; ability to collaborate with sponsors and cross-functional teams.
• Fluent in English (spoken and written).

Responsabilidades

• Serve as a regulatory SME, ensuring alignment with country-specific requirements.
• Oversee regulatory submissions and study start-up oversight.
• Coordinate study documentation and quality control.
• Maintain regulatory trackers and TMF/eTMF systems.
• Support sponsor communications and cross-functional collaboration.
• Ensure audit readiness and regulatory compliance.
• Lead process improvement and operational excellence.

Conhecimentos

Regulatory expertise

Communication skills

Organizational skills

Cross-functional collaboration

Regulatory tracking systems

Formação académica

Bachelor's degree in allied health

Ferramentas

eTMF/TMF systems

Regulatory tracking systems

Microsoft Office

CTIS submissions

Descrição da oferta de emprego

What You'll Do

The Global RASSU Lead will serve as a subject matter expert for clinical trial regulatory requirements, ensuring alignment with country-specific requirements, CTI and sponsor SOPs, ICH/GCP, and applicable regulations. The role will also support regulatory document oversight, study start-up tracking, eTMF/TMF review, audit readiness, training and mentoring, and communication with sponsors and cross-functional teams.

Global and Regional Regulatory Strategy

• Define and oversee regulatory submission strategy in collaboration with sponsors, Project Management, regional teams, and country teams.
• Provide oversight for initial submissions, substantial amendments, non-substantial amendments, and other regulatory submissions, as applicable.
• Support alignment across global, regional, and country-specific requirements to ensure timely and compliant submissions.
• Provide guidance on responses to deficiency letters, information requests, and regulatory authority or Ethics Committee queries.

Regulatory Submissions and Study Start-Up Oversight

• Oversee submission packages to Competent Authorities, Ethics Committees, IRBs/IECs, and other regulatory bodies in accordance with applicable requirements.
• Support EU/EEA submissions through CTIS, including oversight of Part I and Part II activities, as required.
• Coordinate with regional and country teams to ensure completion of national submissions, regulatory documentation, and related requirements.
• Oversee study start-up activities from initial planning through regulatory green light and study closure, as applicable.

Study Documentation and Quality Control

• Coordinate with sponsors, Project Management, Site Budgets and Contracts, and other functional teams to prepare and adapt required study documents.
• Oversee the preparation, review, and adaptation of study documents, including informed consent forms, clinical trial application forms, and other regulatory documents.
• Ensure regulatory documents are complete, accurate, and compliant with SOPs, ICH/GCP, GDPR, and country-specific requirements.
• Maintain strong quality control practices across document collection, review, processing, version control, and filing.

Regulatory Green Light, TMF/eTMF, and Tracking

• Oversee Regulatory Green Light Package preparation, review, tracking, and completion across regions.
• Ensure applicable tracking systems, study start-up modules, eTMF/TMF systems, and regulatory trackers are updated accurately and on time.
• Support TMF/eTMF quality checks, reconciliation, close-out, and archiving in accordance with CTI or sponsor SOPs.
• Monitor study start-up progress and provide clear, accurate status updates to sponsors, Project Managers, and study teams.

Cross-Functional Communication and Sponsor Support

• Act as a key point of contact for regulatory study start-up matters, ensuring effective communication with sponsors, Project Management, regional teams, country teams, and other stakeholders.
• Support sponsor-facing communication related to submission strategy, timelines, document status, regulatory requirements, and issue resolution.
• Collaborate with internal and external teams to identify risks, resolve barriers, and support timely delivery of regulatory milestones.
• Lead or participate in study meetings and regulatory discussions, as assigned.

Regulatory Support, Compliance, and Audit Readiness

• Provide regulatory guidance to project teams regarding clinical trial submission requirements and country-specific expectations.
• Support compliance assessments and escalate notable findings, risks, or delays to Project Managers and RASSU leadership.
• Contribute to preparation for sponsor audits, agency inspections, and regulatory quality reviews.
• Ensure study documentation is audit-ready, properly archived, and aligned with regulatory and sponsor expectations.

Operational Excellence and Process Orientation

• Demonstrate urgency and accountability by prioritizing critical tasks and supporting timely delivery without compromising quality.
• Support Unit Tracking completion and identify potential out-of-scope RASSU study-related activities, as applicable.
• Participate in department and company initiatives to support process improvement, harmonization, and operational excellence.
• Maintain a strong focus on accuracy, consistency, confidentiality, and continuous improvement.

What You'll Bring

• Bachelor's degree in an allied health field such as nursing, pharmacy, health science, natural science, or equivalent relevant experience.
• Minimum of 8 years of relevant research, regulatory, pharmaceutical, site, or CRO experience.
• Strong knowledge of clinical trial regulatory requirements and submission processes, Globally and in EU including EU CTR, CTIS, MHRA, Ethics Committee/IRB/IEC processes, Competent Authority requirements, and applicable national regulations.
• Excellent understanding of ICH/GCP, medical and pharmaceutical terminology, SOPs, GDPR, and clinical trial documentation standards.
• Experience with regulatory study start-up activities, including document preparation, submission package oversight, regulatory tracking, GLP activities, and TMF/eTMF review.
• Experience supporting or overseeing global and regional clinical trial submissions.
• Strong organizational skills with the ability to manage multiple priorities, complex workflows, and time-sensitive deliverables.
• Excellent written and verbal communication skills, with the ability to collaborate effectively with sponsors, project teams, regional teams, country teams, and internal stakeholders.
• Ability to maintain confidentiality and provide a high level of customer service.
• Strategic decision-making, problem-solving, and process improvement mindset.
• Proficiency with Microsoft tools, regulatory tracking systems, study start-up modules, and eTMF/TMF systems.
• Fluent in spoken and written English

Preferred Experience

• Experience working across multiple countries and regions.
• Familiarity with submissions involving medical devices, GMO requirements, import/export documentation or country-specific regulatory processes.
• Experience supporting sponsor audits, agency inspections, or regulatory quality reviews.

About CTI

• Advance Your Career – We invest in your professional growth. Our structured mentoring program, leadership development courses, and dedicated training department provide the support you need to excel. We also encourage ongoing education to help you achieve your professional goals.
• Join an Award-Winning Team – Join a global team spanning 60 countries, recognized for its award-winning culture that prioritizes people. We support your work-life balance with hybrid work opportunities. Through our CTI Cares program, you’ll have opportunities to give back to your community and the world.
• Make a Lasting Impact – At CTI, your work directly contributes to advancing medicine. You’ll play a vital role in developing life-changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most.