Keiona Pasco
Member of The Honor Society of Phi Kappa Phi
From Waterbury, Connecticut
From Waterbury, Connecticut
Regulatory Compliance, Labeling, eCTD & ANDAs
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Keiona Pasco Inducted into The Honor Society of Phi Kappa Phi
Keiona Pasco of Waterbury, Connecticut, was recently initiated into The Honor Society of Phi Kappa Phi, the nation's oldest and most selective all-discipline collegiate honor society. Pasco was in...
February, 28 2018 - Verified by The Honor Society of Phi Kappa Phi
Regulatory Affairs Associate at Breckenridge Pharmaceutical, Inc.
Review technical/regulatory/clinical documentation related to ANDAs, or other applications, as assigned, to support original submissions, amendments, supplements and annual reports.
Write ANDA supplements/amendments sections to support department goals.
Prepare electronic files for inclusion in eCTD submission by creating files using current eCTD Templates and by hyperlinking and bookmarking files per FDA and company procedures.
Evaluate proposed changes to applications versus current available guidance documents and formulate filing strategies for consideration by Regulatory Affairs management.
Prepare and submit Annual Reports in accordance with the established schedule.
Create, revise and maintain drug product labeling.
May 2017 - Present
