Regulatory Quality Systems Specialist

MSD; Carlow; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

Merck & Co., Inc. in Carlow, Ireland is seeking a Quality Systems and Compliance - Regulatory Compliance Specialist to help ensure vaccine and biologics manufacturing meets cGMP and regulatory requirements for safety, quality and reliable supply.

You will lead cross-functional regulatory activities, manage HPRA submissions, maintain master files, support audits, and drive continuous improvement of quality systems across site operations.

Qualifications

• Bachelor’s degree in a science discipline.
• 5+ years in Regulatory Affairs, QA or Regulatory Compliance in GMP/pharma.
• Experience with CMC submissions and health authority Q&A cycles.
• Experience supporting technology transfer and regulatory documentation across functions.
• Licensing activities: Site Master File, HPRA notifications, market accreditations.
• Knowledge of EMA, FDA, ICH guidelines and HPRA requirements.
• Strong data integrity and regulatory document management skills.
• Ability to manage multiple regulatory activities to tight timelines.

Responsibilities

• Comply with CGMP/GDP in day-to-day activities.
• Prepare GMP documentation and respond to agency questions.
• Maintain site master file and regulatory dossiers.
• Support product renewals, re-registrations and tenders.
• Lead regulatory tracking, reporting and knowledge management systems.
• Coordinate audits/inspections and respond to findings.
• Drive cross-functional collaboration to meet regulatory requirements.
• Ensure processes and procedures for all quality activities are followed.

Skills

GMP Knowledge

Regulatory Affairs

Quality Assurance

ALCOA Data Integrity

Documentation Management

CMC Submissions

Audit Readiness

Change Controls

Cross-functional Collaboration

Strategic Thinking

Education

Bachelor’s degree in science

Regulatory Affairs certification

Job description

Merck & Co., Inc. in Carlow, Ireland is seeking a Quality Systems and Compliance - Regulatory Compliance Specialist to help ensure vaccine and biologics manufacturing meets cGMP and regulatory requirements for safety, quality and reliable supply.

You will lead cross-functional regulatory activities, manage HPRA submissions, maintain master files, support audits, and drive continuous improvement of quality systems across site operations.