Job Description

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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