Ohm Labs Jobs in New Jersey
1) Oversee all Compliance related activities -Field Alert Reports (FARs) and Recalls: · Prepare/review FAR and recall related submissions in accordance with the CFR and organizational procedures. · Communicate with the FDA Field Offices for any FAR/recall related submissions/issues/status. · Coordinate internally (Ohm) and with 3rd parties to obtain FAR/recall related documentation and provide reg...
Accountabilities:This position coordinates and ensures effective and timely input into the planning, agreement and generation of required documentation, and the review and compilation of dossiers, as needed, for submissions. Provide leadership to Regulatory Associates and guide them on the commonly practiced procedures within the group (i.e. filing procedures and documentation retrieval). Interact...
Accountabilities:Preparation and review of original eCTD ANDA/NDA submissions, as well as, pre-approval and post-approval applications, within the designated time frames to meet filing schedules and to assure the completeness, accuracy and quality of the application content as well as compliance to current ICH and FDA guidance and regulations Level of Responsibility:Medium/High Scope:US Market Dim...
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