Clinical Trials Regulatory Officer Regulatory Maintenance

Job Summary

The Clinical Trials Regulatory Officer prepares reviews and manages regulatory documentation to support clinical trial submissions in compliance with applicable regulatory requirements. The role provides regulatory support across clinical trial projects ensuring high-quality deliverables adherence to timelines and effective collaboration with internal and external stakeholders.

Key Responsibilities

• Prepare and review regulatory documents for clinical trial submissions.

• Act as Clinical Trial Regulatory Manager (CTRM) on straightforward projects and support complex projects under senior guidance.

• Review scientific and regulatory documentation conduct gap analyses and provide recommendations to stakeholders.

• Prepare compile and maintain clinical trial submission dossiers in accordance with regulatory requirements.

• Provide regulatory guidance and strategic input to internal teams and external clients.

• Support local regional and global clinical trial submissions including European centralized submissions where applicable.

• Ensure project deliverables are completed within scope budget and agreed timelines.

• Maintain high quality standards across all regulatory deliverables.

• Ensure accurate maintenance of systems databases tracking tools and project documentation in line with SOPs.

• Participate in project and system audits as required.

• Perform additional duties as assigned by the Line Manager.

Qualifications & Experience

• Bachelors degree in Life Sciences Pharmacy Health Sciences or a related field.

• 2 - 3 years experience in clinical trial regulatory affairs clinical research or regulatory submissions.

• Knowledge of GCP clinical trial regulations and regulatory submission processes.

• Strong organizational communication and stakeholder management skills.

• Ability to manage multiple priorities while maintaining accuracy and quality.

Key Competencies

• Attention to detail

• Regulatory and scientific review skills

• Project management

• Client focus

• Quality and compliance mindset

• Collaboration and teamwork

• Effective communication skills