Title:  QA Regulatory Affairs Specialist

.

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.

Working Environment and Location

• This position is based from the AICL Kerry plant 
• At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

Working Hours

• Full time hours 
• This is a 12 month FTC 

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.

Role and Responsibilities

• 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.

Essential Qualifications

• BSc or other equivalent qualification.
• QA Experience required

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.
• Exeprience using  SAP, Trackwise Digital (eQMS), Veeva Vault (Quality and RIM Production) 

Benefits

Careers | Astellas

Why Astellas

• 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. 

Learn more at Astellas.com

Our Organisational Values and Behaviours

Skills and Capabilities