10 jobs in Kyowa Kirin International plc.

LEAPING FORWARD TO MAKE PEOPLE SMILE

At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.

Overview

WE PUSH THE BOUNDARIES OF MEDICINE.

LEAPING FORWARD TO MAKE PEOPLE SMILE

At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.

Job Purpose

An experienced regulatory professional, responsible for leading external engagement in the Regulatory and Science Policy forums accessible in the respective region. This entails execution of the Global Regulatory Intelligence Organization (GRIO) process while leading process for the development and submission of Kyowa Kirin’s input externally on regulatory and science policy topics. This position entails Regulatory Policy responsibilities primarily for EU, UK, Switzerland, with limited responsibility for additional markets, e.g. APAC.

Responsibilities

Key Responsibilities:

• Lead/manage the external engagement in the Regulatory and Science Policy forums accessible in the respective regions.
• Represent Kyowa Kirin at relevant external regulatory and science policy conference, industry association working group meetings and forums.
• Represent GRA Regulatory Policy and Intelligence Subfunction and lead Regulatory and Science focused Policy positions in internal forums where government agency and legislative topics are discussed cross-functionally.
• Lead/manage and/or conduct the process for the development and submission of Kyowa Kirin’s input externally on regulatory and science policy topics.
• Develop and/or lead execution of the global/regional regulatory and science policy strateg(ies).
• Lead/manage and/or conduct internal education sessions (e.g. Info Series, Town Hall, Meeting presentations, etc.) on regulatory intelligence topics as needed and/or appropriate.
  
  

• Must have experience working in the pharmaceutical/biotechnology Industry.
• Understanding of Kyowa Kirin’s technologies, products and pipeline preferred.
• Must have experience working in regulatory and science policy role and experience working within industry association groups.
• Proven track record of representation of organization externally and advocate effectively on organization behalf and priorities.
• Prior work experience at a health authority or industry association is a plus.

LEAPING FORWARD TO MAKE PEOPLE SMILE

At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.

WE PUSH THE BOUNDARIES OF MEDICINE.

An experienced regulatory professional, responsible for leading external engagement in the Regulatory and Science Policy forums accessible in the respective region. This entails execution of the Global Regulatory Intelligence Organization (GRIO) process while leading process for the development and submission of Kyowa Kirin’s input externally on regulatory and science policy topics. This position entails Regulatory Policy responsibilities primarily for EU, UK, Switzerland, with limited responsibility for additional markets, e.g. APAC.

• Lead/manage the external engagement in the Regulatory and Science Policy forums accessible in the respective regions.
• Represent Kyowa Kirin at relevant external regulatory and science policy conference, industry association working group meetings and forums.
• Represent GRA Regulatory Policy and Intelligence Subfunction and lead Regulatory and Science focused Policy positions in internal forums where government agency and legislative topics are discussed cross-functionally.
• Lead/manage and/or conduct the process for the development and submission of Kyowa Kirin’s input externally on regulatory and science policy topics.
• Develop and/or lead execution of the global/regional regulatory and science policy strateg(ies).
• Lead/manage and/or conduct internal education sessions (e.g. Info Series, Town Hall, Meeting presentations, etc.) on regulatory intelligence topics as needed and/or appropriate.

• Must have experience working in the pharmaceutical/biotechnology Industry.
• Understanding of Kyowa Kirin’s technologies, products and pipeline preferred.
• Must have experience working in regulatory and science policy role and experience working within industry association groups.
• Proven track record of representation of organization externally and advocate effectively on organization behalf and priorities.
• Prior work experience at a health authority or industry association is a plus.

1 day ago Be among the first 25 applicants

LEAPING FORWARD TO MAKE PEOPLE SMILE

At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life‑changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.

Global Director, Data Architecture

Hybrid: Marlow or Galashiels, UK

To ensure the organisation’s ICT strategy is aligned with its business goals, you will be responsible for analysing business processes, defining the technology needs, and the external environment. You will oversee the strategic direction of our data platforms and products. This role requires a visionary leader with a deep understanding of platform technologies, strong leadership skills, and the ability to drive innovation and growth. Experience in modern cloud data technologies like Azure is a must and an applications landscape such as D365, SuccessFactors, Veeva, Salesforce, etc is beneficial.

• Assessment of our current ICT data strategy, data and technology landscape, conduct a maturity assessment and development of a target data platform and technology blueprint for the organisation
• Develop and maintain business data & applications, integration, and technical architecture domains, ensuring alignment with enterprise‑wide roadmaps and standards
• Define and communicate data architecture principles, standards, and patterns to guide solution design and development of data products across the organisation
• Utilise business acumen and technical understanding to align the organisation’s people, processes and technology to enhance business performance
• Collaborate with Technology stakeholders, especially business partners to understand key business goals, processes, and capabilities
• Develop detailed architecture roadmap, manage vendors/resources, and monitor progress to ensure that architecture strategies are effectively executed
• Analyse and help identifying technology gaps in existing business processes to enhance efficiency, reduce costs, and improve service delivery
• Work closely with various stakeholders, including suppliers, clients and internal teams, to understand their needs and ensure seamless integration of solutions and platforms

• Bachelor’s degree in computer science, Engineering, or a related field; Master’s degree preferred
• Fluent in spoken and written English. Knowledge of spoken and written Japanese is an asset but not must
• Proven experience in the designing and implementation of target Enterprise data and information architectures for global organisations
• Strong expertise in Azure data platforms and standards
• Strong understanding of data platforms, including cloud computing, microservices, APIs, and data management
• Experience with Agile methodologies and project management tools
• Experience with market research methodologies and competitive analysis
• Some experience working within the pharmaceutical industry
• Occasional local and international travel with overnight stays

Kyowa Kirin International is an equal opportunities employer.

LEAPING FORWARD TO MAKE PEOPLE SMILE

At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life‑changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.

Legal Director Regional/EMEA (Marlow, UK)

To provide legal advice and support to operational and commercial functions throughout the business.

• Trusted legal business partner to key stakeholders
• Draft, negotiate and review a broad range of agreements across the UK and EMEA region, including those governing interactions with Health Professionals, Healthcare Organisations and Patient Organisations
• Legal review of Regional and Global Policies & SOPs
• Horizon scanning and implementation of new legislation relevant for KKI
• Provide legal support for observational and real‑world evidence studies, supply and distribution agreements, homecare agreements, early access programmes, market access, late lifecycle management and complex procurement
• Provide training to functional and business colleagues on legal topics relevant
• Create and maintain template documents to assist the legal team and other business functions
• Provide legal and ABPI Code of Practice advice on KKI strategic projects
• Enable best practice sharing across the Region
• Work with other Regions and KKC to improve Global/Cross Regional Contracting process

• UK‑qualified solicitor
• UK affiliate and EMEA Regional experience
• Significant in‑house experience in life sciences in UK and familiarity with the ABPI Code of Practice
• Good understanding of GDPR and relevant legislation in the UK and EU
• A willingness to build on legal skills and knowledge through on‑going professional development
• Sound communication skills
• Ability to work well under pressure and adapt to changing business priorities

Kyowa Kirin International is an equal opportunities employer.

No agencies please.

Overview

Associate Director Global CMC QU – Clinical GMP/GDP

at Kyowa Kirin International plc

Marlow, UK or Hoofddorp, Netherlands

WE PUSH THE BOUNDARIES OF MEDICINE. LEAPING FORWARD TO MAKE PEOPLE SMILE

At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life‑changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.

You will be responsible for providing end-to-end quality oversight of clinical investigational medicinal products (IMPs) in accordance with EU GMP (EudraLex Volume 4), including Annex 13, and EU GDP Guidelines (2013/C 343/01). The role provides independent QA oversight and regulatory support to EU Qualified Persons (QPs), ensuring that certification and release of investigational medicinal products is performed in compliance with EU legal and regulatory requirements. The position maintains quality oversight of CDMOs, packaging sites, laboratories, and Third-Party Logistics providers (3PLs) involved in the manufacture, storage, and distribution of clinical trial material (CTM).

• Provide QA oversight of clinical IMP manufacturing, packaging, testing, release, and distribution activities


• Support EU Qualified Person (QP) certification and batch release processes


• Ensure compliance with EU GMP Annex 13 requirements, including labeling, traceability, accountability, and retention samples


• Review and approve GMP documentation, including batch records, CoAs, deviations, investigations, and quality events


• Lead QA support for clinical technology transfers, process start‑ups, and product lifecycle activities


• Provide quality oversight of clinical supply chain operations, including transportation, temperature‑controlled logistics, and distribution


• Ensure clinical trial materials remain fully traceable throughout the supply chain


• Manage Quality Technical Agreements (QTAs) with CDMOs, laboratories, distribution partners, and 3PL providers


• Plan, conduct, and support risk-based GMP and GDP audits of external partners


• Support regulatory submissions, inspections, and health authority interactions


• Author, review, and maintain Clinical GMP/GDP procedures and quality system documentation


• Ensure compliance with data integrity requirements, including EU GMP Annex 11 and ALCOA+ principles

• Bachelor’s degree in a relevant scientific/technical discipline or equivalent experience in the pharmaceutical industry


• Solid leadership experience within Pharmaceutical Quality in the pharmaceutical Industry, with significant exposure to EU Clinical GMP and GDP


• Prior experience working with a Qualified Person (QP) responsible for investigational medicinal products, as well as experience in batch disposition (release), is preferred for success in this position


• Strong knowledge of EU GMP (EudraLex Volume 4, Annex 13) and EU GDP Guidelines


• Experience with biologics and/or small molecule clinical products


• Demonstrated ability to assess quality and regulatory risk and provide sound compliance judgments


• Experience in QA, QC, auditing, or regulatory affairs within a clinical development environment

UK salary - £80,000-121,000

Netherlands salary - €93,000-140,000

Kyowa Kirin International plc is seeking an Associate Director Global CMC QU to provide end-to-end quality oversight of clinical IMPs in line with EU GMP/EudraLex Annex 13 and EU GDP guidelines. The role includes QP certification support, NGO oversight of CDMOs and 3PLs, and regulatory submissions through the product lifecycle.

The position focuses on ensuring traceability, data integrity, and compliance across manufacturing, packaging, testing, and distribution activities within a global

Overview

GRA Compliance & Quality Champion at Kyowa Kirin International plc, Marlow or Galashiels – United Kingdom.

Supporting global regulatory compliance by driving GxP standards, managing risk, and ensuring audit readiness. Collaborate cross‑functionally to embed quality, deliver robust compliance frameworks, and champion continuous improvement across global regulatory teams.

• Support the implementation and maintenance of global regulatory compliance frameworks, ensuring adherence to corporate policies, procedures, and applicable regulations.
• Proactively monitor GxP compliance across GRA, identifying gaps and driving timely corrective and preventive actions.
• Own and maintain risk registers and compliance dashboards, providing clear visibility to leadership and ensuring effective mitigation of identified risks.
• Oversee the management and timely closure of deviations, change controls, and corrective actions within GRA.
• Define, monitor, and continuously improve GRA metrics and KPIs, ensuring appropriate mitigation actions are implemented and tracked.
• Ensure effective rollout and adoption of new or updated procedures across global and regional teams.
• Champion a culture of quality and compliance, promoting best practices and continuous improvement across GRA.
• Lead global audit and inspection readiness activities, including preparation, training, and ensuring documentation meets regulatory standards.
• Collaborate cross‑functionally (e.g., Quality Assurance and other teams) to embed quality principles within operational activities.

• Degree in Life Sciences (or equivalent) with experience in pharmaceutical Regulatory Affairs.
• Willingness to travel (UK and internationally) with occasional overnight stays.
• Flexible approach to working hours to support global collaboration.
• Strong leadership and interpersonal skills, with the ability to influence and collaborate effectively.
• Excellent communication and negotiation capabilities (written and verbal).
• Highly analytical, with strong problem‑solving abilities and attention to detail.
• Well‑organised, able to manage multiple priorities in a fast‑paced environment.
• Confident in interpreting and presenting complex scientific information.
• A results‑driven mindset, demonstrating urgency and excellence in execution.

Kyowa Kirin International is an equal opportunity employer. No agencies please.