Christina Settle Email & Phone Number

Prepare, review, and submit ANDA amendments, supplements, annual reports, and PADERS in eCTD format.Prepared and successfully submitted an NDA. Worked with team to prepare and submit amendments throughout the review process through approval of the NDA and maintenance of the NDA post approval. Submitted transfer of ownerships of over 100 ANDAs.Preparation, review, and submission of CBE-30s and PASs for manufacturing site change of transferred products.Review and upload labeling in SPL format to DailyMed website.Minor revisions of labeling in SPL format using SPL XForms.Coordinate with Chartwell’s pharmacovigilance contractor for review of adverse events to FDA.Responsible for annual establishment registrations and self-identification.Publishing submissions in eCTD format using Lorenz DocuBridge software and uploading via the ESG.Write and/or review of department SOPs.

Review ANDA supplements, annual reports, and PADERS in eCTD format for submission to FDA.Review and upload labeling in SPL format to DailyMed website.Working with contract manufacturing organizations (CMOs) on developing security data exchange agreements.Working with Virtus’ pharmacovigilance contractor and CMOs on investigation and submission of adverse events to FDA.Recall coordination including sending out notifications to customers, completion of FDA’s recall questionnaire, tracking returns and destruction of recalled materials, conducting effectiveness checks, submitting recall updates to FDA, and corresponding with FDA regarding questions related to open recalls.Filing Field Alert Reports with FDA.Tracking and Trending of Adverse Events and Product Technical Complaints.

Review ANDA submissions, amendments, and supplements in eCTD format for the India regulatory team.Review submissions for dosage forms such as solid oral, ophthalmic, and metered dose inhalents.Correspond with FDA by submitting controlled correspondence requests.Prepare presentations for head of US Regulatory Affairs on subjects such as best practices and FDA’s current opinion on particular subjects.

Coordinate with other departments and third party contract manufacturer’s and laboratories to compile and review ANDA submissions, amendments, and supplements in eCTD format.Correspond with FDA by submitting controlled correspondence requests and contacting project managers regarding status updates of previous requests and current pending submissions.Perform regulatory review and approval of cGMP documents such as test methods, SOPs, batch records, and specifications.Work on developing and continual revision of best practices template for ANDA submissions to reduce future deficiencies.Submit ANDAs and other eCTD submissions to FDA via the Electronic Submissions Gateway.Publish ANDAs and other eCTD submissions within MedexView.

Contribute to ANDA submissions in both CTD and Traditional format by reviewing and writing in areas such as labeling, packaging, and regional documents.Help to prepare amendments and supplements to ANDA’sCreation and submission of Annual Reports, drug listing, and adverse event reporting.Responsible for updating, proof reading, and submitting drug labeling.Write, review, and update SOP’s pertaining to controlled substances and drug labeling.Liaison between Abrika and DEA.Responsible for quota requests, ordering, receiving, shipping, tracking, and disposal of controlled substances.Preparation of controlled substance inventory and periodic reporting to DEA such as ARCOS and year end reporting.

Associate Of Arts (Aa), Communications

Education record