QA Regulatory Affairs Specialist (Co. Kerry, IE)
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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
Courage
Impact
Innovation
Integrity
Accountability
One Astellas
Outcome Focus
Sense of Urgency
Skills and Capabilities
Organizational Focus
Information Technology
Data Management
Research Design
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Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 1075 comparable Quality roles across 129 biopharma companies.
Salary context
197 of 1075 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 1075 comparable roles
+ 48 more countries
Seniority mix
475 of 1075 peers have a known seniority level
Therapeutic area mix
2 of 1075 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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How we calculate "similar"
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Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.