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 and autonomous regulatory professional responsible for independently leading CMC regulatory activities for assigned development products and clinical projects, including CGTs where applicable, while also serving as the recognized RA CMC expert for a specific product type, and/or country/region. The role provides authoritative technical and/or regional regulatory insight that is leveraged across global development programs, ensuring high-quality, compliant CMC regulatory outcomes and proactive risk management under the overall direction of the RA CMC Development Team Lead.

Key Responsibilities:

• Serve as the primary RA CMC Subject Matter Expert and regulatory lead for assigned development products and clinical projects, with end-to-end accountability for CMC regulatory deliverables.
• Act as the designated RA CMC expert for a specific product type and/or country or region, providing authoritative interpretation of regional CMC regulatory requirements and expectations.
• Independently develop and execute CMC regulatory strategies for assigned programmes, ensuring alignment with global development plans and regional regulatory expectations.
• Lead and influence cross-functional development teams (e.g. CMC, Manufacturing, Quality, Supply Chain), ensuring global and regional regulatory requirements are embedded into CMC development plans.
• Lead the preparation, review, and coordination of CMC-related regulatory submissions for development projects, including INDs/IMPDs, CTA/CTN submissions, amendments, and other development-related filings.
• Own the quality, consistency, and timeliness of CMC regulatory documentation and regulatory responses for assigned programmes and regions.
• Support in the preparation of CMC sections of initial global marketing applications, where applicable, ensuring alignment with regional regulatory expectations.
• Act as the regional CMC regulatory lead for CMC focused Health Authority interactions, including development of regional CMC positions, briefing documents, and responses to regulatory questions.
• Represent RA CMC in Regulatory Agency meetings with a CMC focus (e.g. scientific advice, pre-IND, end-of-phase, and pre-submission meetings) as required.
• Proactively identify regional and programme-specific CMC regulatory risks, gaps, and opportunities, developing mitigation strategies and escalating issues appropriately.
• Lead and oversee CMC regulatory activities conducted by external partners, CMOs, and vendors, ensuring regional regulatory expectations are clearly communicated and met.
• Maintain deep and current knowledge of regional CMC regulatory requirements and regulatory intelligence, assessing impact on development programmes and advising global stakeholders.
• Contribute to the development, review, and continuous improvement of SOPs, Work Instructions, and best practices related to CMC regulatory activities, incorporating regional perspectives.
• Provide CMC regulatory leadership and support for GxP inspections and audits related to development and manufacturing activities, including region-specific inspections where required.

• Life science qualification with experience in pharmaceutical regulatory affairs.
• Demonstrated experience in pharmaceutical RA CMC, with a focus on development-stage biological products, including an understanding of CMC requirements across early to late stage clinical development.
• Experience leading global RA CMC strategies for biologics, including co-ordinating cross-functional input and ensuring alignment with program objectives.
• Experience leading CMC-related regulatory submissions for development projects, including authoring or contributing to INDs/IMPDs, CTA/CTNs, Amendments, responses to Health authority questions, and other development-related filings.
• Direct experience interacting with Health Authorities (eg. FDA, EMA, MHRA, national agencies) on CMC-related development topics, including preparation for and participation in scientific advice meetings or similar interactions.

Kyowa Kirin International is an equal opportunity employer.

No agencies please.