Regulatory Affairs Specialist, International Labeling Support (ILS) (Open)
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From MSD’s original posting
Job Description The Specialist, International Labeling Support will partner cross functionally within GRACS and cross divisionally where applicable to ensure all the Labeling and Artworks regulatory operational activities in scope of ILS are planned, managed, and executed timely, accurately and in a compliant way. The role includes any identification of opportunities for process improvement and participation in their implementation. Specific responsibilities include: • Prepares high quality labeling, artwork package aligned with company requirements and provides operational support to Country Regulatory Affairs on regulatory activities (database maintenance, records filings) according to the ILS scope of work. • Supports the preparation of the metrics for the designated business process. • Collaborates with Global Labeling, Country/Regional Regulatory Affairs, for labeling & artworks queries. • Supports necessary process documentation updates and periodic revisions. • Contributes to improvement or re-engineering/simplification of the process and related tools. • Supports the necessary follow-ups and escalations cross functionally and cross divisionally, as applicable after certain…
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