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International Labeling Support Specialist

msd · MYS - Selangor - Petaling Jaya (Ascent Paradigm)

New
Hybrid 🇬🇧 English
Microsoft 365 Regulatory systems Databases Document management systems AI-enabled solutions

Job description

About the role

The International Labeling Support (ILS) Specialist partners with Global Regulatory Affairs and cross‑functional teams to ensure labeling and artwork activities are planned, managed and executed accurately, on time and in full compliance with regulatory requirements.

Key responsibilities

  • Prepare high‑quality labeling and artwork packages that meet company standards and support Country Regulatory Affairs.
  • Maintain regulatory records and databases, ensuring data integrity and timely updates.
  • Coordinate with Global Labeling, CRA and other stakeholders to resolve labeling queries.
  • Track and report metrics for labeling processes and drive continuous improvement initiatives.
  • Update process documentation, work instructions and training materials as needed.

Required profile

  • Bachelor’s degree in Pharmaceutical Sciences, Biotechnology, Life Sciences, Pharmacy or a related discipline.
  • Minimum 2 years of experience in the pharmaceutical, biotechnology or healthcare industry, preferably in regulatory affairs, labeling, CMC or quality compliance.
  • Strong organizational abilities with the capacity to manage multiple priorities and meet deadlines.
  • Excellent interpersonal and communication skills for effective collaboration across regions.

Required skills

  • Proficiency with Microsoft 365 applications.
  • Experience using regulatory systems, databases and document‑management platforms.
  • Ability to apply emerging technologies, including AI‑enabled solutions, to improve processes.

Questions fréquentes

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Source : ats:workday

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Published 7 hours ago

Expires 1 month from now

3 views · 0 interested

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msd

MYS - Selangor - Petaling Jaya (Ascent Paradigm)