The Regulatory Documentation Specialist will support global regulatory submissions and reports for the Somerset manufacturing facility. The Regulatory Documentation Specialist will assist in the identification and development of processes and technical solutions that improve New Product Launch and Regulatory Operations business processes, based on available technologies. Additionally, this position will be responsible for ensuring compliant documents and submissions with in-house job rules and regulatory guidance. The Regulatory Specialist will coordinate work flow and submission timelines including definition of technical specifications for formatting, publishing, and QC at the document level. Working with cross functional teams to complete technical document support to the corporate office in Lake Forest, IL. Execution of the site SOP for Annual Product Reviews (APRs). Effective timeline management and communication relative to submission components. Coordinate and finalize documentation for FDA deficiency responses, ANDA submissions, and audit responses. Perform and write annual product reviews to support product lifecycle. Serve as primary scribe for customer and regulatory audits. Document formatting and QC, in accordance with the applicable project Style Guide. Document-level publishing and QC, in accordance with the applicable project ePublishing Style Guide. Paper submissions management and production, including volumization and the associated headers, footers and tables of contents, overall production planning, production, quality control and delivery. In collaboration with senior regulatory operations staff, manage, design, publish, review, submit and archive of global submissions, including amendments and original filings. Liaise with Regulatory Affairs Project Managers, clients and vendors directly, as necessary, to coordinate submission timelines and technical specifications and for client reviews. Maintaining accurate records, including submission and document publishing and QC logs, delivered submissions and archival. Serving as an internal go to on the Akorn standard Authoring Templates, Medical and Regulatory Writing Style Guide, and the ePublishing Style Guide. Assist in the lifecycle maintenance of the same. Assist Regulatory Affairs personnel and Medical Writers with document-level requirements and best practice techniques for compliant authoring.
Qualifications Bachelors Degree in Biological Science, Chemistry, Engineering, or equivalent education required. Preferred regulatory experience including publishing experience in NDAs, ANDAs, Amendments and Supplements, and deficiency and audit responses.