Kyowa Kirin International

Regulatory Affairs Manager

Job Locations Remote-Remote
Posted Date
4 months ago(28/07/2022 16:33)
Category
Regulatory Affairs

Overview

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

 

This role principally manages Kyowa Kirin regulatory aspects in the EMEA region to ensure that marketing authorisation of products is achieved in a timely manner and post-licensing regulatory activities associated with all Kyowa Kirin’s global marketed products in the partner territories are in compliance with applicable legislation and business requirements. This position supports company vision for the EMEA global geographic expansion.

Responsibilities

  • Compliance with relevant regulatory legislation and guidelines and internal procedures in relation to gaining and maintaining marketing authorisations.
  • Defining project and product regulatory strategy in line with Kyowa Kirin’s International Expansion and Partnership Management strategy;
    • Representation of regulatory affairs in partner and cross-functional team meetings for defined projects, providing information, feedback, and strategic advice.
    • Management of the regulatory activities associated with partnership management plans.
  • Production of all types of regulatory submissions as needed to support the Kyowa Kirin business in the specified territories.
  • Maintenance of regulatory approvals including follow-up of commitments as a condition of approval, and post-approval submissions.
  • Tracking of partner data requests and regulatory submissions, including post approval commitments/measures and other obligations.
  • Management of regulatory product information.
  • Regulatory activities are carried out in compliance with regulatory standards and company standards, such as Standard Operating Procedures (SOPs).
  • Support the continuous improvement of regulatory and cross-functional processes.
  • Support the selection of junior regulatory staff, their development and training.

Qualifications

  • Life science qualification with broad experience in the pharmaceutical industry, and specifically in EMEA and LATAM regulatory affairs.
  • Expert technical knowledge, particularly of module 3 of the Common Technical Document.
  • Expert regulatory knowledge of European and overseas markets, particularly Middle East, Africa and LATAM