Director, Regulatory Diagnostics

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

 General Description: 

 The Director, Regulatory Diagnostics will be responsible for developing, planning, authoring and coordinating IVD/SRD (In vitro Diagnostics/Study Risk Determination) related regulatory submissions in line with program strategies and cross-functional initiatives.  The key responsibilities include both regulatory diagnostic strategy for all phases of development i.e. early to late stage. This individual will represent North America Regulatory Diagnostics on cross-functional teams providing guidance on regulatory strategy and tactics.  The incumbent will also support Global Regulatory Teams, manage at least one individual and coordinate with key stakeholders, as required. The individual will use their regulatory and Diagnostics/IVD expertise to influence cross functional teams the best NA strategy that will support the development of new and existing assets.  Externally, this individual will interface with outside regulatory agencies for application submission and management. 

 Essential Functions:  

• Lead and influence in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with IVD device use for assigned studies. 

• Work with Biomarkers and Translational Medicine organization to gain required clearances for IVD device use for assigned studies. 

• Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory documentation as required for investigation and registration of products in the US and abroad. 

• Support the Vendor/partner evaluations, meetings, ​submission planning 

• Ensure the accuracy of IVD device language for protocols, ICFs, and related study documentation. 

• Ensure regulatory submissions are maintained in compliance with regulatory requirements. 

• Address device inquiries from IRBs, FDA, Health Canada, sites, and partners. 

• Support and manage preparation of meeting requests and briefing documents. 

• Actively Participate on project teams and provide expertise on regulatory matters related to IVD device use and associated risks; advise teams on device strategy. 

• Coordinate with device partners for device use and filing/registration as applicable. 

• Develop and maintain current regulatory knowledge and advise management of significant developments.  

• Prepare and maintain regulatory archives.