NAVERIS is seeking a talented, highly motivated outstanding individual capable of bringing added value to the team. The ideal candidate is dedicated, energetic and detail-oriented, with experience in pharmaceutical or biotechnology industry preferably in a regulated environment.
- Responsible for providing Regulatory compliance support which includes providing assistance with Regulatory Submission and Approval Tracking activities, completing Regulatory checklists, assisting with Regulatory inspection readiness activities, and identifying process gaps and areas for improvements.
- Also responsible for ensuring completeness, accuracy, and delivery of Regulatory documents, and identifying and resolving discrepancies.
- Develops and implements Regulatory Submission and Approval activities including preparation of CLIA, CAP and State certification applications
- Develops and implements periodic regulatory compliance checklist reviews
- Assists in reviewing essential documents to verify regulatory requirements are fulfilled for participation in a clinical study and authorizes the release of investigational product.
- Assists in reviewing and confirming completeness of essential site documents in order to release sites participating in a clinical study to receive investigational product.
- Assists in ensuring completeness, accuracy, and delivery of Regulatory documents to the electronic trial master file, and identifies and resolves discrepancies as needed
- Assists in providing general inspection readiness support by participating in inspection readiness task forces, providing support in staging required regulatory department documentation, and providing Regulatory ready room support during health authority inspections
- Assists in supporting development and maintenance of Regulatory standards and procedures in accordance with all applicable Regulatory regulations, guidance, and specifications.
- Regulatory inspection readiness experience a plus
- Requires knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications
- Can work independently (some guidance from direct manager anticipated), ability to multi-task, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills
- Working knowledge with MS Office applications and Adobe Acrobat. Previous exposure to electronic document management systems (EDMS) is desirable
- 3 years’ experience in pharmaceutical or biotechnology industry preferably in a regulated environment (Regulatory Affairs/Operations, Clinical trial support)