Manager, Regulatory CMC

📋 Description

• • Own the end-to-end authoring, review, and submission of global CMC regulatory packages—from pre-IND through post-approval—for Orca Bio’s next-generation, high-precision cell therapies. You will translate complex manufacturing and analytical data into clear, compliant dossiers that advance life-saving treatments for blood-cancer patients.
• • Lead the creation of briefing documents, meeting requests, and responses for FDA Type B/C, EMA scientific advice, and other health-authority interactions. Your packages will directly shape pivotal discussions that determine program speed and success.
• • Drive Module 2 (Quality Overall Summary) and Module 3 (Quality) content for INDs, IMPDs, BLAs, MAAs, and annual reports, ensuring every section meets current ICH, FDA, EMA, and PIC/S expectations. You will harmonize technical writing across analytical, process-development, and quality-assurance teams to deliver submission-ready documents on aggressive timelines.
• • Craft forward-looking CMC regulatory strategies that anticipate manufacturing scale-up, comparability protocols, post-approval changes, and lifecycle management. You will map regulatory risks—such as raw-material variability or potency-assay bridging—and design mitigation plans that keep programs on track.
• • Serve as the primary CMC Regulatory representative on cross-functional project teams, translating regulatory requirements into actionable technical tasks for Process Development, Manufacturing, Supply Chain, and Quality. Your influence will ensure that every process change, validation study, and stability protocol aligns with global filing milestones.
• • Monitor evolving guidances (FDA CMC, ICH Q12, EMA GMP Annex 1) and competitive intelligence, distilling implications for Orca Bio’s pipeline. You will brief leadership on new expectations and recommend proactive adjustments to development plans.
• • Evaluate proposed manufacturing changes—facility transfers, scale expansions, analytical method modifications—for global regulatory impact. You will author change-control assessments and determine the level of new data required to maintain compliance across jurisdictions.
• • Mentor junior regulatory writers and CMC scientists on best practices for scientific writing, document templates, and agency interaction etiquette. Your coaching will elevate the quality and consistency of all regulatory communications.
• • Maintain a living regulatory roadmap in Smartsheet or MS Project, integrating CMC deliverables with overall program timelines. You will flag bottlenecks early and negotiate resource allocation to ensure on-time submission of critical filings.
• • Champion a culture of urgency, scientific rigor, and patient-centricity. Every document you release carries the potential to accelerate access to therapies that can restore patients’ lives, and you will treat that responsibility with unwavering integrity.