Regulatory Compliance Administrator
About the Role:
We are seeking a detail-oriented Regulatory Compliance Administrator to support our Regulatory Compliance Review (RCR) operations. This role is crucial for ensuring adherence to international guidelines by managing essential document processes and facilitating clear communication across project teams. If you are passionate about regulatory documentation and global compliance, this is a fantastic opportunity to contribute to a world-class organization with remote work flexibility.
Key Responsibilities:
- Conduct global regulatory compliance reviews of essential documents for study-specific Essential Document Checklists (EDCs).
- Respond to inquiries from project teams regarding EDC requirements and regulatory standards.
- Facilitate discussions on deviations from RCR processes, ensuring compliance and transparency.
- Manage and coordinate the Essential Document Checklist Process effectively.
- Maintain current knowledge of PPD SOPs, client directives, and global regulatory guidelines.
- Review, finalize, and post EDCs accurately and on time.
- Support documentation consistency, version control, and process adherence.
Qualifications and Experience:
- Education: Bachelor’s degree in Science, Pharmacy, Life Sciences, or a related discipline.
- Experience: 1 to 3 years of relevant experience in regulatory affairs or clinical documentation.
Key Skills:
- Excellent written and verbal English communication skills.
- Exceptional attention to detail, editorial accuracy, and organizational skills.
- Proficiency in Microsoft Word, Excel, and PowerPoint. Adaptability to new digital tools is a plus.
- Working knowledge of global regulatory submission processes.
- Analytical and problem-solving skills with a collaborative team-oriented mindset.
Benefits of Working with Us:
- 100% remote work flexibility and structured career growth opportunities.
- Exposure to global regulatory frameworks and clinical documentation systems.
- Work-life balance with standard weekday schedules.
- Access to continuous learning and upskilling programs.
- Inclusive and collaborative work environment.
How to Apply:
If you are a highly motivated individual with a passion for regulatory compliance and a desire to contribute to a dynamic team, we encourage you to apply.