Regulatory Affairs Senior Associate 12m FTC en Kyowa Kirin International

Overview

Regulatory Affairs Senior Associate 12m FTC

at Kyowa Kirin International plc

Marlow or Galashiels, UK

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 delivering tasks/processes/products/projects.  Supports the Regional Regulatory Lead (RRL) for global products and/or early/mid phase development projects and/or lead for regional products.  Regional RA lead for global regulatory projects or regional cross-functional projects

Responsibilities

Key Responsibilities:

• Support the creation of regional RA product strategy for assigned licenced products/development projects
• Collaborate closely with cross functional departments to ensure development and/or lifecycle management opportunities are identified and incorporated into regulatory strategy
• Lead/manage (complex) regulatory submissions for assigned development projects/product
• With oversight, contact health authorities on product/project related activities
• Manage/support with regulatory timelines, interactions and regulatory activities with external organisations as needed, for assigned products/development projects
• Collaborate/support RA activities with partners/vendors and ensure compliance with relevant legislation and guidelines for products/development projects assigned (where applicable)
• Support process improvements when operational issues are identified
• Author and review SOPs / WIs to achieve consistency in regulatory standards and compliance
• Support with budget requirements captured in the Regional/Global RA budget
• Escalate potential regulatory risks and issues according to agreed processes
• Provide RA support for GxP inspections/audits as required

Qualifications

Position Requirements:

• Life science qualification with experience in pharmaceutical regulatory affairs

Kyowa Kirin International is an equal opportunities employer.

No agencies please.