Associate Director, Regulatory Affairs

🕒 September 15

🏄 California – Remote

🏄 California – Remote

💵 $180k - $241k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 7%

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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

• Support development and execution of clinical regulatory strategies for assigned programs • Contribute regulatory analyses, options, and recommendations • Plan, prepare, and manage IND applications and other pre- or post-IND submissions • Manage regulatory timelines, deliverables, and commitments with cross-functional teams • Prepare health authority meeting materials, responses to information requests, and supporting documentation • Participate in health authority interactions • Provide clinical regulatory guidance to cross-functional teams • Provide regulatory input into protocols, Investigator’s Brochures, and study reports • Execute regulatory activities in compliance with global and regional regulations, industry guidelines, and internal policies • Maintain inspection-ready documentation and practices • Identify regulatory risks, issues, and gaps and develop mitigation approaches • Lead clinical regulatory execution on cross-functional teams • Coordinate inputs from Clinical, Nonclinical, Biometrics, Medical Writing, CMC, and other functions • Partner with CMC Regulatory Affairs and technical subject matter experts • Monitor regulatory developments and assess potential impacts • Contribute to regulatory processes, templates, and tools

🎯 Requirements

• Bachelor’s degree in life sciences with 10 years' experience in the biopharmaceutical industry, including 8 years in regulatory affairs; or equivalent combination of education, training, and experience • Demonstrated experience preparing and managing INDs and supporting regulatory submissions • Experience supporting health authority interactions and cross-functional development teams • Working knowledge of regulatory requirements and processes in major markets (U.S. and/or EU) • Strong written, verbal, and interpersonal communication skills • Ability to work effectively in a fast-paced, matrixed, and global environment • Maintains the highest standards of integrity and ethics

🏖️ Benefits

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

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