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, responsible for managing and coordinating GRA change controls (CC) and regulatory impact assessments by working with record owners and SMEs to define actions, timelines, and ownership. Oversee change control activities end‑to‑end in QMS and RIMs, ensuring high‑quality records, timely completion, and compliance with SOPs. Serve as the primary RA change control point of contact, support or act as the Regulatory Execution Owner (RAEO), raise regulatory activities, track progress, and contribute to metrics reporting.

Key Responsibilities:

• When a change/deviation is initiated by GRA (and therefore GRA are accountable in entirety for the Change Control in QMS), this role will involve working with the record owner (or be record owner), to:
• Identify SMEs
• Co-ordinate and facilitate meetings
• Work with SMEs to determine change actions (CAs), appropriate timelines and owners.
• Raise CAs in the system (including RA assessment – see actions below)
• Manage activity/record through to implementation and close out.
• When a change is initiated in QMS (by GRA or any other function and GRA are accountable for provision of comprehensive Regulatory Impact Assessment in RIMs), this role will involve:
  • Acting as RA CC window person point of contact. Accountable for ensuring that the contact request is accepted and then actioned by RA.
  • Working with RA CC SME(s)
    • Engage with RA CC SME(s) for pre-CC initiation discussions in order to understand the proposed change scope and assist Change owner/Initiator in developing the highest quality draft record to be entered into Veeva QMS.
    • Ensure smooth transition to the RIMS assigned Event Owner (EO) (ideally act as EO whenever possible/as skills develop).
  • Will be support or act as RAEO within RIM:
    • Raising reg activities
    • Managing progress of record through RIMs (from initiation to close out) ensuring all activities are completed, in accordance with SOPs (all information included for metrics etc) and timelines are met.
    • Assisting in gathering of data for metrics reporting
  • Oversee collaboration with partners/vendors for projects/products assigned and ensure compliance with relevant legislation and guidelines for products/development projects assigned, including selection and onboarding process (where applicable).
  • Lead and support process improvements when operational or strategic issues are identified
  • Ensure personal and team compliance with relevant global regulatory legislation, guidelines and internal procedures
  • Escalate potential risks and issues according to agreed processes.
  • Provide RA support and/or RA lead for GxP inspections/audits as required.
  • Collaborate closely with other sub-functions and functions to ensure strategy, knowledge and best practice are shared and aligned.

Position Requirements

• Life science qualification or other relevant qualifications for role 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 analytical and problem-solving skills.
• Good organisational skills and attention to detail.
• Ability to understand and present basic scientific arguments.
• Maintain as part of the whole regulatory team Kyowa Kirin Core Competencies: Results Orientated, Sense of Urgency and Flawless in Execution.

Kyowa Kirin International is an equal opportunity employer.

No agencies please.