POSITION REQUIREMENTS:

• Life science qualification with experience in pharmaceutical regulatory affairs
  Kyowa Kirin International is an equal opportunities employer.
  No agencies please

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

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