MSD

Regulatory Affairs Associate Specialist, International Labeling Support (ILS)

CZE - Central Bohemian - Prague (Five)Posted 6 days ago
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From MSD’s original posting

Job Description The Associate Specialist, International Labeling Support will support cross-functional collaboration within GRACS and, where applicable, cross-divisionally to help ensure that Labeling and Artwork regulatory operational activities in scope of ILS are planned, coordinated, and executed in a timely, accurate, and compliant way. The role contributes to routine operational activities, supports issue resolution under guidance, and may identify practical opportunities for process improvement. Specific responsibilities include: • Supports the preparation of high-quality labeling and artwork packages and all related activities aligned with company requirements and provides routine operational support to Country Regulatory Affairs on regulatory activities, such as database maintenance and record filing, according to the ILS scope of work. • Engages with Global Labeling, Country/Regional Regulatory Affairs, on labeling and artwork queries, with guidance from more experienced team members as needed. • Assists with process documentation updates and periodic revisions under guidance. • Contributes to process improvement or simplification initiatives by providing operational…

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