Regulatory Affairs Associate

at Kyowa Kirin International plc

Scotland, Galashiels

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

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

Key Responsibilities:

• Supports the creation of regional RA submission strategy for assigned licenced 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 organizations 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.

Position Requirements

• 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 negotiations skills.
• Good organisational skills and attention to detail.