Head of Biologics, China CMC Regulatory Affairs

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Job Description

OBJECTIVES/PURPOSE

• Leads and oversees the development and implementation of regulatory CMC development and registration strategies for the Biologics CMC team. China RA CMC member on Global Regulatory CMC, Global Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial life cycle for assigned products and staff.
• Demonstrates high level of leadership and expert understanding of CMC and quality regulations and guidelines and expert up-to-date CMC knowledge and skill to address and overcome challenges that arise during development and commercialization.
• Manages and/or mentors staff members.
• Development constructive relationships with proactively communicates issues to key internal and external stakeholders.
• Provides regulatory CMC expertise for new business development/due diligence activities.
• Combines knowledge of scientific, regulatory and business issues to ensure the registration and life cycle maintenance (CMC regulatory aspects) of China products are of high quality and right first time, to contribute to enhance China business process.
• Align China implementation strategies and plans with global CMC plans and teams. Enable China CMC projects’ success in meeting goals/objectives.

ACCOUNTABILITIES

• Responsible for demonstrating Takeda leadership behaviors, lead for all CMC regulatory relevant activities for the Biologics CMC team.
• Independently plans, executes and manages regulatory submission for assigned products in various phases of clinical development, marketing applications, and post -approval life cycle activities, ensure Global/ China strategy are successfully executed across both new product development and existing portfolio life cycle management.
• Leads the development and implementation of China CMC regulatory strategies for assigned products and communicate to global CMC regulatory teams and stakeholders in a timely manner.
• Leads 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.
• Leads Health Authority CMC communication, CDE technical review, CMC 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.
• Builds and manages constructive relationships with key internal (GRA, GRA CMC, Asia development team, GMS, GQ etc.), to provide timely and high quality CMC regulatory support and input.
• Builds and manages constructive relationships with key external stakeholders (NIFDC, IDC, CPC, CDE, CFDI, RDPAC etc.),  to drive Takeda positions and influence scientific approach and though process to CMC topics.
• Provide support and coach to  CMC regulatory colleagues in the team to solve the CMC problems occurred during CMC project registration to achieve CMC projects registration approvals in a timely and effective manner.
• Support the line manager, to develop and improve expertise and capabilities for the China Regulatory CMC team to ensure enabling both the pipeline and maintenance of products through innovative and proactive CMC regulatory  strategies.
• Manages and develops staff, including staff professional development and project oversight accountability.
• Leads and/or contributes to business development and enhancement.
• Evaluate new business development opportunities or participant on due diligence teams.
• Ensure compliance with all applicable Takeda SOPs, local and international regulations, and industry best-practice.
• EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
• BS/BA Degree required with 10+ years of relevant Industry, academic or HA experience; advanced degree preferred
• Experience with CMC regulatory and regulatory for biologics, or equivalent industry experience.
• Minimum 3 years managing teams in a matrix team environment or managing people.
• 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.
• 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 expected.

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