Regulatory Compliance Specialist

2 weeks ago


Dublin, Dublin City, Ireland beBeeRegulatory Full time €120,000 - €145,000
Regulatory Compliance Specialist Job Description

Serve as a Qualified Person (QP) to ensure certification and batch release of clinical trial supplies in compliance with EU regulations. Maintain a thorough understanding of relevant EU regulations.

Act as a Responsible Person (RP) for Wholesale Distribution Authorisation (WDA) on Pre-Approval Access activities, ensuring regulatory compliance and operational efficiency.

Support global regulatory authority inspections and audits (GMP/GDP), encompassing the clinical and commercial supply chain. Develop strategies for quality issue management, regulatory compliance, and continuous process improvement.

Maintain and update Site Master Files and Manufacturing Authorisations to guarantee adherence to regulatory standards.

Elevate awareness of significant quality issues or deviations to stakeholders and senior management through prompt communication.

Review, approve, and manage procedural and quality documentation to ensure alignment with regulatory requirements and internal policies.

Pursue collaborative efforts with cross-functional project teams and strategic working groups within Quality and Supply Chain functions.

Offer expert guidance to foster alignment with external regulations and internal policies at a global and cross-functional level.

Represent the organization in interactions with regulators, trade bodies, and professional associations to promote regulatory compliance.

Identify and contribute to mitigating quality and compliance risks, while developing effective audit programs.

Cultivate ongoing professional development and champion Operational Excellence (OPEX) initiatives to drive quality system improvements and cultural enhancements.



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