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Job Description

ACCOUNTABILITIES

• Independently plans, executes and manages regulatory submission for assigned products in various phases of clinical development, marketing applications, and post -approval life cycle activities.
• Independently develop and implement China CMC regulatory strategies for assigned products and communicate to global and local stakeholders in a timely manner.
• Lead CMC submission dossier preparation, ensure high quality CMC submission complying with external and internal requirement to provide right and clear drug profile and data to NMPA to achieve targeted drug features to be approved.
• Member of global/ China cross-functional teams which require experienced interpretation of applicable ICH/WHO/Global/China regulation to ensure CMC compliance within the organization.
• Independently handle CMC communication with Health Authority, CDE technical review, meetings with Health Authorities on CMC related matters.
• Lead sample registration testing in NIFDC/IDC, to support related registration approval.
• Lead Health Authority on-site inspection on CMC RA related matters.
• Develops and maintains constructive relationships with key internal (GRA, GRA CMC, Asia development team, GMS, GQ etc.), and external stakeholders (NIFDC, IDC, CPC, CDE, CFDI, RDPAC etc.).
• Ensure project team colleagues, line management and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in professional and timely manner. Provides solutions to prevent recurrence of issues.
• Evaluate new business development opportunities or participate on due diligence teams.
• Evaluate change proposals for regulatory impact and plans global variations and amendments.
• Manages and develops staff, if required, including staff professional development and project oversight accountability.
• Ensure compliance with all applicable Takeda SOPs, local and international regulations, and industry best-practice.

Qualifications & Skills:

• BS/BA Degree required with 8+ years of relevant Industry, academic or HA experience; advanced degree preferred
• Experience with CMC regulatory and regulatory, or equivalent industry experience.
• Proven ability to liaise with Regulatory Agencies having served as lead in Agency interactions and product development meeting.
• Understanding of scientific principles and regulatory requirements relevant to drug development and post-market support.
• Proven ability to provide strategic regulatory guidance to drug development, registration and post market support teams.
• Able to deal with issue of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
• Demonstrated leadership, problem-solving ability, flexibility and team work.
• Demonstrated ability to work well within a matrix structure in a complex environments.
• Exercises good judgement in elevating and communicating actual or potential issues to line management.
• Excellent written and oral communication skills required.
• Active participation in Agency/ industry groups/forums preferred.

Locations

CHN - Beijing - Research and Development

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time