Senior Director, Regulatory Affairs and Quality Assurance
Come join our world‐class team evaluating, in‐licensing and developing innovative therapeutic products internationally.
HUYA Bioscience International is a biopharmaceutical company focused on globalizing products from China and Asia for the world markets in multiple therapeutic areas. The Company’s lead compound in oncology, HBI‐8000, which is already approved for lymphoma in China, is in late stage clinical development in Japan and Korea. In the United States, the compound is being developed in immune‐oncology (IO) in multiple tumor types and disease settings. HUYABIO has a pipeline of IO compounds as well as two other compounds for cardiovascular diseases. More information can be found at www.huyabio.com
Brief Description of Job Requirements
Directs functions within Regulatory Affairs and executes Quality Assurance/Control operations within the US. Prioritizes tasks to ensure departmental timelines are met. This position successfully and efficiently manages multiple projects simultaneously and adapts to changing project priorities. Instills, promotes, and maintains a culture of organizational excellence and leads by example. Requires a dynamic leader with outstanding communication and collaboration skills.
Regulatory Affairs responsibilities include, but are not limited to:
- Manage the assembly of high‑quality submissions to health authorities (including IND, DMF, NDA, DSUR), formatted and edited in accordance with the corporate style guide, in collaboration with the appropriate functional areas
- Collaborate with CROs who provide regulatory support in ex‑US regions and manage regulatory submissions to FDA
- Execute the role of System Administrator of the company’s EDMS, MasterControlTM, used to prepare and archive regulatory submissions and supporting documentation
- Create and implement organizational policies and standards to maintain corporate regulatory compliance
- Accountable for the accuracy of regulatory submissions
- Develop, implement, and manage regulatory operation tools, such as a corporate style guide and eCTD templates, and processes, such as document review and approval
- Work closely together with various functional areas, including Clinical Development and Operations, CMC, and Nonclinical
- Identify, liaise with, and manage a service provider to publish regulatory submissions according to eCTD requirements and submit electronically to regulatory authorities within the US
- Review and assess regulatory documents for consistency, accuracy, and conformance with applicable regulatory requirements
- Stay abreast of the evolving regulatory landscape and communicate changes and updates within the organization
Quality Assurance responsibilities include, but are not limited to:
- Oversee review and approval of contract manufacturing documentation, such as validation protocols and reports, batch manufacturing records, deviations, analytical methods and method validation protocols and reports, stability protocols and reports, and process and development reports
- Manage the audit program for GxP contract service providers
- Implement and manage quality systems, including CAPA, Change Control, and product complaint reporting
- Develop, maintain, and periodically review the Quality Manual, Policies, and SOPs across functional areas (GxP)
- QC review data to ensure consistency and adherence to applicable policies, SOPs, and specifications
- Manage training in the MasterControlTM EDMS and maintain periodic GxP training programs
- Maintain a working knowledge of applicable regulations to ensure compliance with GxP requirements
- Perform QC of regulatory submissions and associated supporting documents and communicate findings to the appropriate functional area
- Responsible for the Document Control function, both for hardcopy and electronic documents, and oversee the establishment and maintenance of internal documentation organization and retention to meet regulatory requirements and corporate needs
The position is full‐time and the candidate must be within commuting distance to HUYABIO’s Del Mar, CA headquarters. Interested candidates should submit resumes to: email@example.com.
To learn more about HUYA Bioscience, please visit www.huyabio.com. HUYA Bioscience is an equal opportunity employer.
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