• Excellent working knowledge and advanced experience with FDA/ICH guidances for INDs, sNDS, NDAs, ANDAs, BLAs and major supplements/amendments.
• Collaborative knowledge of eCTD publishing, IND, NDA, IND-NDA annual reports, NDA/ BLA cover sheet, eCTD filing and authoring submissions.
• Experience in Regulatory Publishing using eCTDXPress, FirstDoc (Documentum), ISI toolbox, Adobe Acrobat Professional & MS Office, Lorenz Validator.
• Knowledge of internal and external publishing standards for US, EU and Canadian Submissions.
• Thorough knowledge of 21 CFR part 11, FDA, GMP, GCP and GLP standards.
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