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Job Description

OBJECTIVES/PURPOSE

• Facilitate the PDT China portfolio expansion strategy and implementation. S/he leads new products policy/regulation advocacy and regulatory environments shaping to secure the new products’ readiness and implementation, to deliver and serve the patients in China.

• In accordance with the company’s product launch strategy, lead and coordinate the process of drug registration in China and ensure the compliance of technical documentation and process to guarantee the success of drug registration.

• Implement related registration work of new product during the registration cycle to ensure Import Drug License approval.

ACCOUNTABILITIES

• Develop registration strategy in accordance with the company’s product launch plan. Be fully responsible for the product registration and application for approval.
• Lead the local project team to solve the problems that occurred during drug registration process and get drug registration approvals timely as planned. Manage the necessary materials and information during the process,  tracking the progress and keep teams informed timely.
• Be responsible for submission of complete and qualified product application materials/data to drug regulatory authorities, coordination of raw data review and on-site assessment.
• Manage and archive all registration materials and other relevant documents in proper system based on Takeda SOP/Best practise. Responsible updates tracking project status/key informations as team aligned into proper folder/system.
• Provide necessary support to the preparation and implementation of local clinical trial/MRCT ; site/remote inspectionas; QC test; MKT launch as needed.
• Work with GRL/delegates, Global Regulatory Affairs CMC & Device, Quality, Medical Affairs, Operations, IT and other business functional heads to ensure a streamlined, coordinated and global approach to new product introduction.
• Establish influential relationships with key regulatory authority individuals and KOLs in relevant fields, such as NMPA, CDE, NIFDC,etc. Monitor regulatory environment and collect important information such as regulations, guidelines, competitive products and etc.
• Represents China PDT RA as an authorized official or responsible person in interactions with regulatory agencies, associations and taskforces. Direct interfaces with regulatory authorities as needed on issues.  Maintains a positive relationship with regulatory officials and responds to inquiries in a timely fashion.
• Ensure that regulatory policies and procedures are written and implemented in accordance with all applicable Chinese and industry regulations and requirements. 
• Others assigned by line manager.

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 & Skil:

• 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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