Regulatory Affairs Director

This innovative, patient-focused, commercial-stage biopharmaceutical company is based in China and the United States. They are seeking a Regulatory Affairs Director who can lead the development and implementation of Regulatory strategies for a key late-stage oncology asset. Reporting into the VP of Regulatory Affairs, you will work closely with cross-functional teams and interact directly with Health Authorities. This company offers a strong development pipeline, excellent funding, competitive compensation, and flexible work arrangements. With their lead program in Phase 3 trials, now is an exciting time to join this growing organization. Responsibilities: Global Regulatory Strategy: Lead the development and execution of regulatory strategies for assigned assets, ensuring alignment and coordination across regions. Regulatory Submissions: Oversee the planning, preparation, and management of regulatory submissions for assigned programs, ensuring quality and timely delivery. Health Authority Engagement: Serve as a primary point of contact with FDA and EMA, leading or supporting meetings and communications. Ensures alignment of global Health Authority engagements with product strategy. Compliance: Ensure compliance with all applicable government regulations, industry guidelines, and internal policies for assigned programs. Regulatory Guidance: Interpret regulations, policies, and guidelines; advise cross-functional teams on regulatory requirements to support product development. Risk Management: Identify, assess, and proactively manage regulatory risks, developing and executing mitigation strategies. US/EU Regulatory expertise: Provide regulatory expertise for US and EU regions, identifying and mitigating country-specific risks, supporting local submissions, and ensuring adherence to local regulations. Cross-Functional Collaboration: Demonstrates a constructive and positive approach when working with colleagues. Encourages the exchange of information and the adoption of best practices. Represent Regulatory Affairs in cross-functional teams and governance forums, providing regulatory expertise throughout the product lifecycle. Regulatory Intelligence: Monitor and communicate changes in the regulatory environment and assess their impact on Zai Lab’s portfolio. Process Improvement: Contribute to the enhancement of regulatory processes and systems for greater efficiency and compliance. Maintain the highest standards of integrity and ethics. Contribute to building an open and trust atmosphere. Work across several time zones and travel up to 30%. Qualifications: Bachelors degree in life sciences required. Advanced degree such as MS, PhD, or Pharm D preferred. 12 or more years of experience in Regulatory Affairs for pharmaceutical drugs and/or biologics. Must have strong Regulatory experience with oncology programs. Experience with biologics a plus. Proven track record of successful interactions with US FDA and other Health Authorities. Must have direct experience with IND filings. Experience in preparing major drug applications (NDA, BLA, etc.) strongly preferred. Demonstrated success in developing and executing regulatory strategies across different stages of development. Proven experience leading health authority interactions and negotiations, and managing regulatory submissions. Strong knowledge of regulatory requirements and processes in major markets. Ability to interpret and apply regulations, policies, and guidelines to support product development. Excellent organizational, communication, and interpersonal skills. Strong analytical and problem-solving abilities, with a proactive approach to risk management. Experience representing Regulatory Affairs in cross-functional teams and governance forums. Ability to work effectively in a fast-paced, matrixed, and global environment across several time zones NOTE: This role is based in South San Francisco, CA. Only local candidates in the Bay Area will be considered. Must be in the office 3 times per week. The budgeted salary range for this position is $225,000 to $250,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.

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