Global Labeling Operations Specialist

Merck Gruppe - MSD Sharp & Dohme; Petaling Jaya; Hybrid; MYR 78,000 - 100,000; Full time

Job summary

Merck Gruppe - MSD Sharp & Dohme seeks a Specialist, International Labeling Support (ILS) to partner across GRACS and divisions to plan, manage, and execute labeling regulatory activities. The role maintains regulatory records, drives process improvements, and supports local labeling implementation.

The candidate will work with CRA and Global Labeling, ensuring timely, accurate deliverables and contributing to metrics and documentation updates in a hybrid environment.

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Biotechnology, Life Sciences, Pharmacy, or related discipline is preferred.
• Minimum 2 years of experience in the pharmaceutical, biotechnology, healthcare, or related industry.
• Experience in Regulatory Affairs, labeling/artwork management, CMC, quality, compliance, or regulatory operations is preferred.
• Strong organizational skills and ability to manage multiple priorities and deadlines.
• Good interpersonal and communication skills across functions and regions.
• Detail-oriented with focus on quality, accuracy, and compliance.
• Proficient in Microsoft 365 applications.
• Open to exploring AI-enabled solutions to enhance business processes.

Responsibilities

• Prepares high-quality labeling and artwork package aligned with company requirements and supports Country Regulatory Affairs for regulatory activities (database maintenance, regulatory record management) within ILS scope.
• Ensure labeling and artwork deliverables are completed accurately and within established timelines.
• Supports the preparation of metrics for the designated business process.
• Collaborates with Global Labeling, CRA, and other stakeholders to resolve labeling and artwork-related queries.
• Supports updates to process documentation, work instructions, and training materials.
• Participate in cross-functional initiatives to identify opportunities to improve, simplify, and streamline processes and tools.

Skills

Biological Sciences

Biotechnology

Process Documentation

Regulatory Affairs

Pharmaceutical Regulatory Affairs

Detail-Oriented

Emerging Technologies

Operational Excellence

Life Science

Regulatory Compliance

Education

Bachelor's degree in Pharmaceutical Sciences or Life Sciences

Job description

Merck Gruppe - MSD Sharp & Dohme seeks a Specialist, International Labeling Support (ILS) to partner across GRACS and divisions to plan, manage, and execute labeling regulatory activities. The role maintains regulatory records, drives process improvements, and supports local labeling implementation.

The candidate will work with CRA and Global Labeling, ensuring timely, accurate deliverables and contributing to metrics and documentation updates in a hybrid environment.