RAC Case Manager
OhioHealth
Senior Regulatory Affairs Associate
Kyowa Kirin Co., Ltd.
contract
Posted on:
Origin: • 🇬🇧 United Kingdom
Visit company websiteJob Level
Senior
About the role
- 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
Requirements
- Life science qualification with experience in pharmaceutical regulatory affairs
