Job Description

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.

Qualifications

Position Requirements

• 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.