Employer requires a Masters degree in Drug Regulatory Affairs, Clinical Research, Biomedical Engineering or related technical field plus 60 months experience in job offered, Regulatory Affairs Associate, Research Associate, Research Scientist, or related occupation. Experience must include 1 Preparation and review of DMFs to support drug substances, excipients, packaging components used for Drug product, 2 Review of change control documents and provide approval, 3 Drug Establishment registration, GDUFA Self ID submission, SPL labeling submission, 4 Preparation of Controlled correspondences and meeting requests to FDA and health agencies, and 5 Review and preparation of technical reports, Study protocols, method validation reports.
Categories: eb3
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