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Job Description

Regulatory Affairs Lead, China PDT is responsible for supporting the PDT BU’s global plasma sourcing strategy for China. S/he also leads local regulatory policy initiatives related to plasma and plasma sourcing to help ensure network flexibility and continuous supply of PDTs to patients in need in China.  

The Regulatory Affairs Lead, China PDT:

• Provides proactive leadership, strategic guidance and oversight for the human plasma sourcing group by defining and optimizing  regulatory strategies, objectives, and policies for the development, registration and lifecycle management of source plasma in China RA team.

• Serves as the primary contact with China HA, including NHC,NMPA, NIFDC, SHIDC, and global plasma sourcing stakeholders.
• Maintains a strong and proactive communication channel with China Health Authorities on all plasma sourcing related matters.
• Closely collaborates with the Global Plasma & RA CMC Team on regulatory plasma-related strategy issues, bringing innovative and timely approaches to regulatory and compliance requirements for existing and future products.
• Manages all aspects of plasma sourcing relative to local variation submissions, operations, tracking and approvals to ensure consistency with global strategy, and on time approvals from the HA.
• Builds and maintains a strong communication/discussion line with global PDT RA teams to ensure alignment and harmonization of FDA, EMA and NMPA regulatory requirements and regulatory policy initiatives.
• Enhances the awareness of China plasma sourcing regulations and intelligence, and hosts plasma sourcing communication meetings/education sessions, with key PDT stakeholders as global PDT RA, GMS, SITE, GQ, and other relevant stakeholders.

ACCOUNTABILITIES

• Provide proactive leadership, strategic guidance and oversight for the human plasma sourcing group by defining and optimizing  regulatory strategies, objectives, and policies for the development, registration and lifecycle management of source plasma in China RA team.
• Work with Global Regulatory Affairs CMC & Device, Quality, Medical Affairs, Operations, IT and other business functional heads to ensure a streamlined, coordinated and global approach to plasma sourcing.

• Serve as the primary contact point and liaison with China regulators to obtain timely health authority decisions and guidance.
• Represents China PDT RA as an authorized official or responsible person in interactions with regulatory agencies. Directly interfaces with regulatory authorities as needed on issues.  Maintains a positive relationship with regulatory officials and responds to inquiries in a timely fashion.
• Take a actively engage with key internal and external stakeholders in supporting legislative or statutory changes in plasmapheresis requirements.
• Represent PDT RA in China relative trade association committees and task forces. Develop regulatory and business strategies that support the plasma collection industry and patient groups.
• Work together with global RA to the development of strategic and tactical objectives, plans and programs for Regulatory Affairs. Advise senior management concerning regulatory requirements and the impact on project status and company compliance. 
• Ensure that regulatory policies and procedures are written and implemented in accordance with all applicable local and industry regulations and requirements. 
• Directly responsible for the development and implementation of programs, policies and standard operating procedures to meet global regulatory requirements and to ensure operational efficiency and effectiveness within PDT China RA.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Extensive knowledge of regulatory requirements and demonstrated ability to function as the lead interface with Regulatory Authorities (e.g., NHC, NMPA,NIFDC…).
• Demonstrated ability to develop and implement regulatory strategies, facilitate approvals, resolve complex issues, and negotiate optimal regulatory pathways and outcomes with health authorities.
• Ability to use precedent and previous experience to develop innovative and flexible approaches to achieve goals.

Leadership

• Ability to motivate, mentor and manage a diverse team in a matrix environment.
• Global perspective with a demonstrated ability to work across functions, regions, and cultures.
• Ability to identify potential challenges and opportunities and make recommendations.

Decision-making and Autonomy

• Accountable for acting decisively and exercise sound judgment in making decisions with limited information.
• Ability to challenge self and others to overcome regulatory barriers and deliver high quality solutions to the business.
• Accountable for making clear business arguments and strategic recommendations leveraging both quantitative and qualitative evidence.

Interaction

• Valuing and promoting differences by recognizing the importance of connections and brings in key stakeholders to work towards the best possible solutions.
• Exceptional communication, negotiation, presentation, and influencing skills across internal and external stakeholders.

Innovation

• Disruptive thinker with the ability to influence and change how Takeda PDT uses data to make decisions and set priorities.
• Ability to identify areas for process and systems innovation and implement change that will enhance the overall effectiveness of the team.

Complexity

• Delivers solutions to abstract problems across functional areas of the business. 
• Recommends key decisions, escalates key issues per agreed governance framework, and persuades key stakeholders through exceptional influencing skills.
• Resilient and comfortable working through large scale global change management

Qualifications & Skills:

• Bachelor’s degree required.  Advanced degree in biological sciences or related fields preferred.
• 10+ years in a regulatory role of increasing responsibilities in the biologics or plasma field.
• Strong technical background including familiarity with China HA regulations related to plasma collection and/or manufacturing.
• Extensive experience in China submission, review and managing RA project with HA.
• Demonstrated ability to lead teams and collaborate with key cross functional areas. To work in a matrix environment
• Ability to motivate, mentor and manage a diverse team in a matrix environment.
• Strong oral and written communication and negotiation skills
• Highest level of compliance integrity and business adaptability
• Expertise written English and smooth oral English  

ADDITIONAL INFORMATION

• Domestic and international travel is required.

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