Principal Rassu Specialist

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 reg