Specialist, International Labeling Support

MSD Malaysia; Makati; On-site; PHP 800,000 - 1,100,000; Full time

Benefits offered by this job

Hybrid work arrangements

Job summary

MSD Malaysia is seeking a Specialist, International Labeling Support to join our GRACS team in a global pharma environment. You will coordinate labeling and artwork tasks, support local labeling implementations, and ensure regulatory records are maintained and compliant.

The role requires a Bachelor's degree and at least 2 years in pharma regulatory operations, with strong organizational skills, Microsoft 365 proficiency, and openness to AI-enabled solutions.

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Biotechnology, Life Sciences, Pharmacy, or related field
• Minimum 2 years in pharma/biotech/healthcare or related industry
• Experience in Regulatory Affairs, labeling/artwork management, CMC, quality, or regulatory operations preferred
• Experience with regulatory systems/databases/document management is a plus
• Strong organizational skills and ability to manage multiple priorities and deadlines
• Excellent interpersonal and communication skills across functions and regions
• Detail-oriented with focus on quality and compliance
• Proficient in Microsoft 365 applications; open to AI-enabled solutions

Responsibilities

• Prepare high-quality labeling and artwork packages aligned with company requirements
• Provide operational support to Country Regulatory Affairs for regulatory activities
• Ensure labeling and artwork deliverables are completed accurately and on time
• Assist in preparing metrics for designated business processes
• Collaborate with Global Labeling, CRA, and other stakeholders to resolve queries
• Support updates to process docs, work instructions and training materials
• Participate in cross-functional improvements to simplify processes and tools

Skills

Biological Sciences

Biotechnology

Regulatory Affairs

Process Documentation

Operational Excellence

Detail-Oriented

Regulatory Compliance

Microsoft 365

Education

Bachelor's degree in Pharmaceutical Sciences

Tools

Microsoft 365

Job description

Job Description Specialist, International Labeling Support

The Opportunity Exciting opportunity to join an innovative and trusted Global biopharmaceutical company Permanent Full-time opportunity Work autonomously whilst being supported, encouraged and being part of a trusted Global leading Pharmaceutical organization The Specialist, International Labeling Support (ILS) will partner cross functionally within Global Regulatory Affairs & Clinical Safety (GRACS) and cross divisionally where applicable to ensure Labeling and Artworks regulatory operational activities within scope of ILS are planned, managed, and executed timely, accurately and in a compliant way. The role is responsible for supporting local labeling implementation activities, maintaining regulatory records and databases, and driving operational excellence through continuous process improvement initiatives.

What you will do:

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

What You Must have

• Bachelor's degree (Pharmaceutical Sciences, Biotechnology, Life Sciences, Pharmacy, or a related discipline is preferred)
• Minimum 2 years of experience in the pharmaceutical, biotechnology, healthcare, or related industry.
• Prior experience in Regulatory Affairs, labeling and artwork management, CMC, quality, compliance, or regulatory operations is preferred.
• Experience with regulatory systems, databases, or document management systems is an advantage.
• Strong organizational skills with the ability to manage multiple priorities and meet deadlines.
• Good interpersonal and communication skills, with the ability to collaborate effectively across functions and regions.
• Detail-oriented with a strong focus on quality, accuracy, and compliance.
• Proficient in Microsoft 365 applications
• Open to exploring emerging technologies, including AI-enabled solutions, and applying them creatively and responsibly to enhance business processes and ways of working.

Required Skills:

• Biological Sciences
• Biotechnology
• Business Processes
• Continuous Process Improvement
• Detail-Oriented
• Emerging Technologies
• Life Science
• Operational Excellence
• Pharmaceutical Regulatory Affairs
• Pharmaceutical Sciences
• Process Documentation
• Regulatory Affairs Compliance

Preferred Skills:

• Communication
• Creativity
• Customer Engagement
• Empathy
• FDA Regulations
• Global Force Management
• Incentive Compensation
• Medical Affairs
• Organizational Behavior
• Regulatory Compliance
• Sales

Employee Status: Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements: Hybrid Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date: 08/28/2026

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century.