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About the Role

As a regional representative in the Technical CMC domain, you will connect global teams and country stakeholders, driving CMC strategy, regulatory affairs, product launches, and quality/compliance activities to deliver value to patients. Based in Tokyo, this role is crucial for supporting drug research and development through product lifecycle management.

Responsibilities

• Serve as the primary point of contact for Technical CMC in the assigned region, coordinating with internal and external stakeholders.
• Understand regional regulatory requirements and market needs, incorporating them into development, launch, and commercialization strategies.
• Provide regional perspectives to the Technical Leadership Team and relevant departments for CMC development, product launch, and commercialization plans.
• Prioritize CMC activities for multiple products and assets, supporting decision-making.
• Manage and communicate the progress, risks, challenges, and key milestones of the regional portfolio to stakeholders.
• Lead cross-functional teams to resolve issues and drive projects.
• Facilitate global and local communication platforms and workshops.
• Lead or support regional technical projects, managing progress and reporting outcomes.
• Provide technical support for CMC regulatory submissions and authority inquiries.
• Support the development and execution of risk assessments and mitigation plans.
• Evaluate and drive Change Controls.
• Author technical reports and scientific rationale documents.
• Support regulatory authority interactions, inspection readiness, and quality/technical audits.
• Participate in Regulatory Intelligence and Quality Management Process activities.
• Drive continuous improvement initiatives to enhance operational efficiency and process standardization.
• Stay updated on the latest trends through external communities and academic activities, disseminating knowledge within the organization.
• Act as the Technical CMC cross-functional point of contact for assigned regions.
• Seek mutual understanding and alignment of local key stakeholders on technical-related topics across assets and translate them into meaningful insights for product development and lifecycle management.
• Manage country selected CMC projects across assets, from early and/or late development to end of commercialization, encompassing the regional specificities and regulations.
• Ensure regional compliance and access of our products, promoting a launch excellence and sustainable framework.
• When applicable, assist with the exploration, establishment, and maintenance of a regional supplier and manufacturing network, in support of local & global commercial and development products strategies.
• Understand regional specificities and regulations, get local alignment, and provide one "Country voice" input to the Technical Leadership Teams, TST’s or any key relevant stakeholders in the CMC development, launch and commercial plan.
• With a cross-asset holistic view, prioritize CMC requests for assets and brand programs, provide local expertise advice and influence decisions to bring greater market value to the region.
• Consolidate a regional portfolio view, with key CMC milestones and business/commercial considerations to highlight key messages, risks, challenges, priorities to Technical Leadership and relevant stakeholders.
• If applicable, coordinate the "PUR." (i.e. Country Product User Requirement) which includes all the country specificities and market specific demand into the overall CMC program.
• Lead cross-functional teams when applicable to deliver and implement proper solution.
• Lead global/local cross-functional communication platform and workshops to ensure a continuous level of mutual understanding and alignment on Regulation, UCB processes, projects, issue escalations and organization across assets.
• Regular and active members of sub-TST’s or core TST’s when applicable.
• Ensure appropriate communication from/to key stakeholders (country functions) and TST’s, i.e. progress update, issue escalation, key decisions, major changes, resource constraints, etc.
• Contribute to the Technical Leadership community by driving/participating to improvement initiatives and sharing learnings across assets.
• Participate to external forums to broaden knowledge and understand future trends.
• Lead/coordinate/support regional technical projects/activities as appropriate, taking into consideration sustainable (green) approaches.
• Monitor and report the ongoing performance of the regional activities.
• Contribute to the TST’s and launch team as appropriate.
• Provide reliable technical advice and expertise to the country teams: support business case evaluation, contribute to the CMC regulatory submission package or RtQ (Request to Questions) wherever it is needed, provide risk assessments and appropriate mitigation plans in alignment with global/local policies, contribute to key decisions, lead and/or assess change controls, etc.
• Authoring reliable technical reports or rationales when appropriate.
• Collect an in-depth understanding of the regional ecosystem and specificities (market/indications/patient dynamics and Health Care system aspects).
• Guarantee compliance to regulations (pharma and ecosystem) by identifying and proposing appropriate mitigations to the global and local key stakeholders.
• Promote a culture of continuous improvement (i.e. COGs reduction), bringing consistency and efficiency in UCB processes across assets by capturing and integrating the One Country Voice in transversal initiatives.
• Support the RIN (Regulatory Intelligence) Corporate Quality Management Process and assessment/mitigation/implementation as appropriate.
• Participate to the regional assessment of proposed changes, as part of the Product Change Control process.
• Contribute to the preparation and/or facilitation of regulatory meetings and/or inspections as appropriate.
• Support and facilitate Regional Quality, Regulatory/Health Authorities or EHS audits, and any technical visits as appropriate.

Requirements

• Master's Degree or Ph.D. in a scientific discipline (Pharmacy, Bioengineering, Chemistry, Biology or related sciences).
• Experience in CMC, formulation development, or process development within the pharmaceutical industry.
• Business-level English proficiency (ability to discuss and facilitate).
• Native-level Japanese proficiency.
• Excellent technical knowledge of biopharmaceuticals, chemical drugs, or regenerative medicine.
• Experience in project leadership and cross-functional stakeholder management.
• Knowledge of regulatory requirements (PMDA) and pharmaceutical lifecycle management.
• Technical Expertise: Strong chemical and/or biological technical background to understand and support UCB portfolio regional strategies and its implementation.
• Gathering and interpreting information: Uses quantitative and qualitative methods to obtain relevant information about stakeholders' needs.
• Delivering impactful results: Get things done but set priorities that contribute to value creation for sei and team.
• Works collaboratively: Use open and honest communication and influencing skills to work effectively within teams and across functions.
• Thinking holistically: Manage the impact that decisions and changes will have on the broader organization.
• Championing change: Adapt self and (project) team to changing circumstances and priorities.

Skills

• Technical CMC
• CMC strategy
• Regulatory affairs
• Product launch
• Quality and compliance
• Stakeholder management
• Project management
• Cross-functional team leadership
• Risk assessment
• Change control
• Technical reporting
• Regulatory intelligence
• Quality management
• Process improvement
• Process standardization
• Communication
• Analysis
• Problem-solving
• Decision-making
• Adaptability
• Biopharmaceuticals
• Chemical drugs
• Regenerative medicine
• Technical transfer
• Quality assurance
• Technical Operations
• Supply chain management
• Manufacturing network management

Location

• Tokyo

Work Type

• Full-time

Experience Level

• Mid-level
• Senior-level

Education Level

• Master's Degree
• Ph.D.

Benefits

• Opportunity to be involved in product launches, manufacturing process development, and approval applications at a biopharmaceutical company.
• Opportunity to participate in the organizational expansion phase of a growing company and advance in a global interaction environment.

About the Company

• UCB is a global biopharmaceutical company focused on neurology and immunology.
• Approximately 8,500 employees worldwide are inspired by patients and driven by science.
• At UCB, we value creating value, not just performing tasks.
• We strive to achieve results for patients by embracing challenges, collaborating, and pursuing innovation.
• We foster a compassionate and supportive culture where everyone is respected, accepted, and can do their best.
• We are always looking 'beyond' to deliver human-centered value for patients, employees, and the planet.
• Working at UCB allows you to experience personal growth, build your career freely, and reach your full potential.

Equal Opportunity

• UCB values equal opportunity.
• All hiring decisions are made without regard to any legally protected attribute.
• If you require special accommodations during the selection process to fully demonstrate your strengths and abilities, please contact EMEA-Reasonable_Accommodation@ucb.com.
• Please note that this contact is only for consultations regarding special accommodations in the selection process.