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: Maintenance of IND/CTAs and/or NDAs/MAAs Regulatory strategy Regulatory intelligence Agency meeting management and correspondence Global/regional labeling Regulatory operations The fellow will have the
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the fellowship, the fellow will work within Regulatory Affairs to gain experience in: Maintenance of IND/CTAs and/or NDAs/MAAs Regulatory strategy Regulatory intelligence Agency meeting management and
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fellows with a comprehensive introduction to the structure, responsibilities, and impact of a Medical Affairs department, both within the organization and in its interactions with the broader healthcare
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fellows with a comprehensive introduction to the structure, responsibilities, and impact of a Medical Affairs department, both within the organization and in its interactions with the broader healthcare
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the fellowship, the fellow will work within Regulatory Affairs to gain experience in: Maintenance of IND/CTAs and/or NDAs/MAAs Regulatory strategy Regulatory intelligence Agency meeting management and
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), labeling, and health authorities' interactions, while collaborating with cross functional teams across Clinical, Safety and CMC. The program also includes a 6-month rotation in Commercial Regulatory Affairs