1. Collaborate with cross-functional teams to ensure adherence to GCP standards and regulatory requirements throughout the BLA submission process.
2. Perform quality assurance audits of clinical trial data, ensuring data integrity, consistency, and compliance with established protocols and regulations.
3. Develop and maintain quality systems and procedures related to GCP compliance and BLA submissions, identifying areas for process improvement and implementing corrective actions as necessary.
4. Provide guidance and support to project teams on GCP compliance issues, regulatory requirements, and best practices for BLA submissions.
5. Coordinate with regulatory affairs personnel to prepare and compile documentation for BLA submissions, ensuring timely and accurate submission to regulatory authorities.
6. Stay abreast of changes in regulatory requirements, industry trends, and best practices related to GCP compliance and BLA submissions and communicate updates to relevant stakeholders.