Clinical Trials Regulatory Officer - Regulatory Maintenance

Clinical Trials Regulatory Officer 2 (Regulatory Maintenance Associate)

Job Overview

The Clinical Trials Regulatory Officer 2 (Regulatory Maintenance Associate) is responsible for managing regulatory activities for maintenance studies, ensuring compliance with applicable regulations, guidelines, and company processes. The role focuses on preparing and maintaining global core clinical trial submission dossiers, supporting EU Clinical Trials Regulation (CTR) modifications, and providing regulatory guidance for ongoing clinical trials.

This position requires effective collaboration with internal and external stakeholders to ensure timely, accurate, and compliant regulatory deliverables throughout the study lifecycle.

Key Responsibilities

• Prepare, review, and maintain global core clinical trial submission dossiers in accordance with regulatory requirements and company standards.

• Support the preparation and submission of maintenance-related regulatory filings, amendments, and modifications, including EU CTR submissions through CTIS.

• Ensure regulatory documentation remains current, accurate, and compliant throughout the lifecycle of assigned studies.

• Provide regulatory guidance and strategic input to project teams and clients regarding maintenance study requirements and submissions.

• Partner with internal and external stakeholders to support regulatory deliverables and study objectives.

• Develop a clear understanding of project scope, timelines, deliverables, and budget considerations to ensure successful execution.

• Monitor regulatory activities and proactively manage timelines to meet project milestones and client expectations.

• Maintain internal systems, databases, regulatory tracking tools, and project plans with a high level of accuracy and attention to detail.

• Support quality and compliance initiatives by ensuring documentation is inspection and audit ready.

• Identify regulatory risks, communicate concerns appropriately, and contribute to the development of effective solutions.

Qualifications & Experience

Required

• Bachelor's degree in Life Sciences, Pharmacy, Health Sciences, or a related field.

• 3 years of experience in clinical trial regulatory affairs, clinical research, or regulatory submissions.

• Knowledge of Good Clinical Practice (GCP), clinical trial regulations, and regulatory submission processes.

• Experience working with the European Clinical Trials Regulation (EU CTR) and Clinical Trials Information System (CTIS).

• Strong organizational, communication, and stakeholder management skills.

• Demonstrated ability to manage multiple priorities while maintaining accuracy, quality, and attention to detail.

Key Competencies

• Strong attention to detail and commitment to quality.

• Excellent planning, organizational, and time management skills.

• Ability to work independently and collaboratively within a global team environment.

• Effective problem-solving and critical-thinking abilities.

• Strong customer focus and stakeholder engagement skills.

• Ability to prioritize competing demands and work effectively under deadlines.

• Commitment to regulatory compliance and continuous improvement.

Why Join Us?

In this role, you will contribute to the successful maintenance of global clinical trials by ensuring regulatory compliance and timely submissions that support the advancement of innovative therapies and improve patient outcomes worldwide.