Senior Manager, Regulatory Affairs, Dx/CDx and Medical Devices, China

of the job:

• Lead the development and implementation of regulatory strategies for assigned China Dx/CDx and Medical Device programs.
• Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory documentation as required for investigation and registration of products in China.
• Ensure accuracy of Dx/CDx-related language in protocols, ICFs and other study documents.
• Ensure regulatory submissions and activities comply with applicable regulatory

• .
• Support health authority interactions, including meeting preparation, briefing packages and responses to regulatory inquiries.
• Lead interactions with China device health authorities, diagnostic partners and other external stakeholders, as applicable.
• Provide regulatory expertise and strategic guidance to study teams on Dx/CDx and Medical Device matters.
• Coordinate with diagnostic partners on product development and registration activities, as applicable.
• Support cross-JAPAC regional initiatives, as needed.
• Monitor regulatory requirements, guidance and industry trends, and communicate regulatory impacts to stakeholders.
• Support regulatory processes, tools, best practices, policy initiatives and regulatory intelligence activities.
• Maintain accurate regulatory records and documentation in accordance with internal procedures.
• Support additional regulatory and cross-functional initiatives in line with evolving business objectives and organizational priorities.

Education Required:

Bachelor’s degree or above in pharmacy, Medical, Biology or related field

Core Competencies, Knowledge and Skill Requirements:  

• Knowledge of China regulatory requirements and registration pathways for IVDs, CDx, and Medical Devices.
• Strong understanding of CDx development and drug-diagnostic co-development principles.
• Proven ability to work effectively in a cross-functional and matrixed environment.
• Demonstrated ability to independently lead regulatory activities and proactively drive complex projects to completion.
• Excellent verbal and written communication skills, with the ability to communicate complex regulatory issues to internal and external stakeholders.
• Strong interpersonal, negotiation, and stakeholder management skills.
• Proven ability to build collaborative relationships and influence diverse stakeholder groups.
• Ability to manage competing priorities and multiple projects simultaneously.
• Experience interacting with regulatory authorities, external business partners, and diagnostic companies.
• Strong problem-solving skills and the ability to apply sound regulatory judgment in dynamic situations.
• Detail-oriented self-starter with the ability to independently drive complex regulatory activities and manage competing priorities in a fast-paced, cross-functional environment.

Experience:

• Minimum of 7 years of experience in the biotechnology, pharmaceutical or diagnostics industry, including at least 4 years in regulatory affairs. Direct experience in IVD/CDx development is strongly preferred.

• Experience with IVD/CDx, biomarker development and regulatory pathways.
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Other Qualifications:    

• Travel: Minimal travel (<10%).