Regulatory Affairs Associate

LEAPING FORWARD TO MAKE PEOPLE SMILE

At Kyowa Kirin International (KKI), our purpose is to make people smile. It means more than drug discovery and development; it is about embedding care into everything we do to make a difference for those who need it most. We are an inclusive pharmaceutical company that takes time to understand what really matters to patients, families, and 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 push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.

Regulatory Affairs Associate

Kyowa Kirin International plc

Scotland, Galashiels

A regulatory professional (developing to an experienced level), responsible for delivering on tasks, processes, products, and projects. Supports the Regional Regulatory Lead for global products and/or early/mid‑phase projects and/or leads for regional products.

• Supports the creation of regional RA submission strategy for assigned licensed products/development projects while ensuring alignment with regional/global product strategy/guidance to optimise regulatory outcomes and maximise product value.
• Collaborate closely with cross‑functional departments to ensure development and/or lifecycle management opportunities are identified and incorporated into regulatory strategy.
• Execute regional regulatory strategy under close supervision.
• Lead/manage regulatory submissions for assigned development projects/products with supervision, including managing the preparation and submissions of Wave 2 Marketing Authorisation Applications (MAA).
• Ensure maintenance of marketing authorisations including follow‑up of commitments as a condition of approval for assigned products under supervision.
• Manage/support regulatory timelines, interactions and regulatory activities with external organisations as needed, for assigned products/development projects.
• Ensure region label is aligned with CCDS (where applicable).
• Collaborate/support RA activities with partners/vendors and ensure compliance with relevant legislation and guidelines for products/development projects assigned (where applicable).
• Ensure compliance with relevant regulatory legislation, guidelines and internal procedures.
• Escalate potential regulatory risks and issues according to agreed processes.
• Support out‑licensing activities.
• Provide RA support for GxP inspections/audits as required.

• Life science qualification with experience in pharmaceutical regulatory affairs.
• Ability to travel (local and international) with overnight stays.
• Flexibility of working hours.
• Good verbal and written communication and interpersonal skills; developing negotiation skills.
• Good organisational skills and attention to detail.