QA Regulatory Affairs Specialist – 12-month FTC
Astellas is a global life sciences company committed to transforming science into value for patients. We provide therapies in oncology, ophthalmology, urology, immunology, and women's health.
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and take intelligent risks while acting with integrity.
Location and Working Environment
Position based in the Kerry (Killorglin) Plant, requiring onsite work.
12-month FTC.
Working Hours
Full time.
Purpose and Scope
Review and maintain regulatory submission documentation to ensure site compliance. Initiate global change controls and manage implementation status. Respond to internal and external regulatory queries. Maintain GMP documents such as specifications, annual report, manufacturing authorization, variation control tables, and site master file.
Responsibilities And Accountabilities
Maintain regulatory documentation compliance by supporting technical reviews, tracking submission of variations, and coordinating site implementation timing.
Update in-house variation control tables, batch release strategy documents, and notify relevant personnel.
Respond to internal and external regulatory queries from QA groups locally and globally.
Prepare documents and samples for product registration, liaising with internal departments.
Support global regulatory affairs requests for CPPs, GMP certificates, declaration letters, CoAs, arranging legalization of documents and raising purchase orders as necessary.
Coordinate with regulatory affairs in Europe, US, and Japan on proposed changes impacting regulatory submissions, preparing local and global change controls.
Submit annual report to US and support Canada CPID preparation and submission.
Maintain GMP documents such as product specifications at AICL(KP), site master file, manufacturing authorization, and relevant SOPs.
Required Qualifications
BSc or equivalent qualification.
Preferred Qualifications
Industrial/pharmaceutical experience.
Regulatory affairs experience.
Familiarity with regulatory requirements of Europe, USA, and Japan.
What awaits you at Astellas?
Global collaboration within a connected community.
Real world patient impact through life‑changing therapies.
Relentless innovation and pushing boundaries.
Culture of growth and development.
Our Organisational Values and Behaviours
Impact
Innovation
Integrity
One Astellas
Accountability
Courage
Sense of Urgency
Outcome Focus
Benefits
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.
#J-18808-Ljbffr