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Associate Director, Regulatory Affairs, Labeling - Job ID: NJ
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$180,000 - $200,000 a year
- The Regulatory Affairs (RA) Associate Director, Labeling will be responsible for labeling activities across programs and stages of development, with specific responsibility for the United States and the Americas and supporting global needs as required.
- The RA Associate Director, Labeling will be overall responsible for ensuring compliance with US regulatory requirements for labeling, and for coordinating internal labelling activities and processes for regulatory submissions and product maintenance.
- Perform global label competitive intelligence, and make recommendations for actions
- Experience in systems (e.g. document management systems, labeling systems, etc.
- Recognize when to provide labeling guidance to product strategy teams, product review teams, HA response teams, labeling stakeholders, junior team members, or others as needed
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