QA Regulatory Affairs Specialist

DescriptionQA Regulatory Affairs Specialist – 12-month FTCAbout Astellas Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com Are you driven to make a real difference in the lives of patients? We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact. Location and Working Environment This position is based in the Kerry (Killorglin) Plant and will require onsite working This is a 12-month FTC Working Hours Full time Purpose and Scope The review and maintenance of the Regulatory Submission Documentation/Dossiers to ensure site compliance with dossier submission. Initiation of Global change controls and management of implementation status. Responding to internal and external regulatory queries. Maintenance of GMP documents such as Specifications, Annual Report, Manufacturing Authorisation, Variation Control Tables and Site Master File. Responsibilities And Accountabilities

• Maintain regulatory documentation/dossier compliance by: (a) Supporting technical compliance reviews where requested, (b) Tracking the submission of variations and approval progression, (c) Coordinate site implementation timing to maintain regulatory compliance.
• Updating of In-house Variation Control Tables/ Batch Release Strategy Documents and notification to the relevant personnel.
• Respond to internal and external queries from the regulatory and QA groups (locally and globally).
• Preparation of documents and samples from registration of Products and liaise with internal departments on their preparation.
• Support requests from global regulatory affairs groups for CPPs, GMP certs, Declaration Letters, CoAs etc. Arrangement of legalisation of documents as necessary, including the raising of purchase orders for such documents.
• Liaising with regulatory affairs in Europe, US and Japan with respect to proposed changes to materials / procedures at AICL(KP) which may have an impact on regulatory submissions. Preparation of local and global Change Controls where required to manage appropriate progression.
• Preparation and submission of Annual Report to US and support Canada CPID preparation and submission as necessary.
• Maintenance of GMP Documents such as: Specifications for products manufactured at AICL(KP), Site Master File, Manufacturing Authorisation and relevant SOPs.

Required Qualifications

• BSc or other equivalent qualification.

Preferred Qualifications

• Industrial/pharmaceutical experience would be an advantage. Regulatory affairs experience is an advantage. Familiarity with regulatory requirements of Europe, USA and Japan (including their associated territories) is an advantage.

What awaits you at Astellas?

• Global collaboration: Work within a connected global community dedicated to improving patient lives.
• Real world patient impact: Contribute to life changing therapies that help people worldwide.
• Relentless innovation: Be part of an organisation pushing scientific and operational boundaries.
• A Culture of Growth: Thrive in a supportive workplace that values development and progression.

Our Organisational Values and Behaviours

• Impact
• Innovation
• Integrity
• One Astellas
• Accountability
• Courage
• Sense of Urgency
• Outcome Focus

Benefits Careers | Astellas 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. Beware of recruitment scams impersonating Astellas recruiters. Authentic communication will only originate from verified company email addresses or official LinkedIn profiles.