Director, Regulatory Affairs (Office based 3xweek)

The Director Regulatory Affairs is responsible for leading the development and execution of regulatory strategies for assigned assets ensuring alignment and execution across regions. This role collaborates closely with other regulatory team members to prepare and manage submissions leads interactions with health authorities and ensures compliance with evolving regulatory requirements. Additionally the Director serves as the US / EU regulatory lead identifying and mitigating country-specific risks supporting local submissions and ensuring adherence to local regulations. The role involves representing Regulatory Affairs in cross-functional teams and governance forums.

This position reports to the VP Regulatory Affairs (US / EU) and is based in our South San Francisco CA office.

• 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 Labs portfolio.
• Process Improvement : Contribute to the enhancement of regulatory processes and systems for greater efficiency and compliance.
• Maintains the highest standards of integrity and ethics. Contribute to building an open and trust atmosphere.  Ability to work across several time zones and travel up to 30%.

Qualifications : REQUIRED

PREFERRED

Additional Information :

The pay range for this position at commencement of employment is expected to be between $221K and $246K / year; however base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and experience. The total compensation package for this position may also include other elements including a sign-on bonus restricted stock units and discretionary awards in addition to a full range of medical financial and / or other benefits (including 401(k) eligibility and various paid time off benefits such as vacation sick time and parental leave) dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department / team performance and market factors.

At Zai Lab we are proud of the gender diversity of our company and our promotion of women in biotech. We have achieved gender base pay equity at all levels 59% of our employees are women and 53% of our management positions are held by women. We are committed to the health of patients and our planet. Thats why our environmental protection social responsibility and corporate governance strategy called Trust for Life is integrated within our business.

Disclaimer : This description is not intended to be construed as an exhaustive list of duties responsibilities or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time as needed.

All qualified applicants will receive consideration for employment without regard to race sex color religion sexual orientation gender identity national origin protected veteran status or based on disability.

Zai Lab is committed to protecting the privacy and security of the information we collect and to being transparent about the purposes for which we use your information. We have a  Privacy Notice which sets forth our policies and practices for handling the information we collect and use in the employment context.  Privacy Notice available upon request.

Remote Work : No

Employment Type : Full-time

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Experience : years

Vacancy : 1