Senior Director, Regulatory CMC

Job not on LinkedIn

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $258k - $320k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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Zai Lab

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2014

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $857.5M Post-IPO Equity on 2021-04

Healthcare • Biotechnology • Pharmaceuticals

Zai Lab is an innovative, research-based, commercial stage biopharmaceutical company based in China and the U. S. focused on bringing transformative medicines for oncology, immunology, neuroscience, and infectious diseases to patients in China and around the world. Their mission is to provide innovative treatments to patients with unmet medical needs, significantly impacting global health.

📋 Description

• Lead global CMC regulatory strategy and execution for small molecule and biological projects across all development phases • Lead preparation of global CMC regulatory submissions, including IND/CTA, NDA/BLA, and MAA applications • Oversee end-to-end CMC dossier preparation, review, and finalization • Develop and implement regulatory CMC strategies, focusing on late-stage development and post-approval GMP-related regulatory support • Serve as primary CMC contact for health authority interactions with NMPA, CDE, FDA, and EMA • Lead pre-IND/NDA/BLA meetings and responses to regulatory questions • Lead regulatory risk assessments, identify key CMC issues, and define mitigation activities • Provide strategic regulatory CMC guidance to cross-functional project teams • Ensure regulatory submissions comply with applicable regulations and guidelines • Lead and manage a team of CMC regulatory professionals, including mentoring, performance management, and career development • Develop internal regulatory CMC guidance, working instructions, and process improvements • Maintain current knowledge of regulatory requirements, guidelines, and technical trends • Collaborate with QA/QC, R&D, manufacturing, and external partners

🎯 Requirements

• PhD in a scientific discipline with eight years of regulatory experience, or equivalent combination of education, training, and experience • RAC certification is a plus • Excellent verbal and written communication skills in both English and Chinese • Ability to articulate complex regulatory issues clearly and concisely • Deep scientific understanding of small molecule and biologics CMC principles, including development processes, manufacturing, and controls • Thorough knowledge of international regulatory requirements and guidelines, including ICH, NMPA/CDE, FDA, and EMA • Proven experience with global submissions • Proven track record leading CMC regulatory submissions, including INDs, NDAs, and BLAs • Successful interactions with health authorities • Demonstrated leadership success as a people manager, with experience building and developing teams • Strong strategic thinking, creative problem-solving, and decision-making abilities • Detail-oriented with strong project management, negotiating, and interpersonal skills

🏖️ Benefits

• Sign-on bonus • Restricted stock units • Discretionary awards • Medical benefits • Financial benefits • 401(k) eligibility • Paid vacation • Paid sick time • Paid parental leave