789051
Compliance Manager RA Manager Regulatory Affairs Manager
Dublin North Dublin South Dublin West
Negotiable
Flexi Start,Relocation package,Parking,Pension,VHI,Educational assistance,Canteen
5 - 6 Years
Permanent Full-time
Third Level Degree
Ciaran McArdle
dublin@brunel.ie
Regulatory Affairs Manager
An excellent opportunity has arisen for a Regulatory Affairs Manager to join one of our client's market leaders in the pharmaceutical industry based in Dublin South.
As a Regulatory Affairs Manager you will be responsible for operating at a senior level within a plant-based CMC (Chemistry, Manufacturing and Control) regulatory team in supporting Marketing Authorisations (MA) of products manufactured by organisation and varying and maintaining existing MAs.
Regulatory Compliance is a major part of this role. Working with a team to prepare/review regulatory strategies and execute through an effective partnership with functional groups drawn from the wider organisation.
Manage the regulatory aspects of the Global Product Conformance (GPC) project and work with cross functional team to conduct comparative analysis vs. registered dossiers, remediation planning and execution for products produced at the plant.
Ensure that GPC remediation and process/system activities are in line with other plant priorities, timelines, and product stock and distribution needs
Job Responsibilities:
· Regulatory Guidance -Excellent technical knowledge in regulatory Affairs
· Regulatory Conformance
· Manage major regulatory system/project
· Review products for conformance to MA
· Supervise and Mentor junior staff members, as appropriate
· Compliance -Attend plant change control committee as needed
· Support for compliance initiatives
· Regulatory Support -Participate in and provide guidance to company project teams
· Prepare regulatory strategies for changes to existing CMC MA data
· Represent GRA at global Company meetings
· Coordinate meetings to track progress of projects and resolve issues
· Regulatory System Support
· Participate in the planning and implementation of Regulatory systems, as needed e.g. change control systems
Person Specification:
· The ideal candidates will hold a relevant qualification in a related discipline from a recognised institution, ideally a BSc or equivalent
· Typically 8+ years of Pharmaceutical industry experience with at least 6 years within regulatory affairs
· An ability to communicate effectively both internally and externally is essential
To apply for this position in strict confidence, please contact Ciaran McArdle in Brunel Recruitment on
+353 1 432 1510 or email your full CV to: cmcardle@brunel.ie
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