Regulatory Affairs Senior Associate 12m FTC
Location: Marlow or Galashiels, UK
Overview
Regulatory Affairs Senior Associate 12m FTC at Kyowa Kirin International plc.
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
* Support the creation of regional RA product strategy for assigned licensed 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 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
* Life science qualification with experience in pharmaceutical regulatory affairs
Kyowa Kirin International is an equal opportunities employer.
No agencies please.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Legal
Industries
* Pharmaceutical Manufacturing
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