Kyowa Kirin Co., Ltd.

Compliance

• 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
• Collaborate/support RA activities with partners/vendors and ensure compliance with relevant legislation and guidelines
• Support process improvements and author/review SOPs / WIs
• Support with budget requirements captured in the Regional/Global RA budget
• Escalate potential regulatory risks and provide RA support for GxP inspections/audits as required

Senior Regulatory Affairs Associate