• Author comprehensive safety assessment reports for inclusion in BLA submissions, ensuring scientific accuracy, clarity, and regulatory alignment • Prepare and draft high-quality responses to FDA Information Requests related to BLA safety content • Collaborate with Pharmacovigilance, Clinical, Regulatory Affairs, Biostatistics, and Medical teams to ensure consistency and completeness of safety narratives and analyses • Contribute to integrated summaries of safety, risk-benefit analyses, and other safety sections required for regulatory filings • Ensure documents comply with FDA, ICH, and global regulatory standards • Assist in drafting, editing, formatting, and maintaining safety-related SOPs and associated work instructions • Ensure SOPs align with current regulatory requirements and internal quality standards • Support inspection readiness activities as needed