Job Description

Job Title:  Regulatory Affairs Specialist

Pay:  $25.00 - $27.00

Job Overview:  The Electronic Submissions Specialist is responsible for building and publishing electronic submissions to Drug, Biological, and Device Regulatory Agencies.  Collaborate with Regulatory Affairs Specialists to establish a project schedule that supports the submission deadlines and to advise them on the quality requirements of the electronic documents.  Review and understand FDA electronic submission guidance and ensure expectations are met in each and every document and submission.  Provides advice on the correct placement of files within the XML backbone, naming conventions, correct level of TOC and hyperlinking as well as being primary users/resource for the operation of the SDMS, eCTD manager and Global Submit validation software.  Submissions will range from single documents to thousands of documents in a submission and cover various formats such as word, pdf, SAS transport and study tagging files. Correct issues arising from the validation.  Provide status updates to leadership keeping them apprised of team progress and/or escalating where needed to achieve desired outcomes. 

Submission Publishing and Compiling:
o Adheres to established Quality/Regulatory Procedures demonstrating sound knowledge regarding technical and regulatory publishing skills concerning internal/external compliance requirements
o Maintains and enhances knowledge of industry standards through effective knowledge-sharing
o Develops publishing strategy to improve business process and/or address publishing issues without significant impact to timeline and resources
o Demonstrates proficient skills concerning utilizing publishing tools and serves as a credible resource to others
o Accountable for accomplishing objectives/goals and takes initiative to improve performance to align with expectations
o Anticipates potential barriers in achieving objectives/goals and acts to correct plans to ensure that goals are met with reasonable timelines
o Drives high standards of publishing quality and utilizes various techniques, and critical thinking, to achieve desired results

Requirements:  

• BS / BA is preferred and 1 - 3 years of regulatory publishing experience in the pharmaceutical industry; preferably eCTD experience
• Understanding of the CFR, FDA/ICH guidelines and cGMP’s, as it pertains to electronic submission processing
• Proficient computer skills especially with Microsoft and Adobe Acrobat applications.
• Detail-oriented and effective organizational skills
• Strong verbal and written communication skills
• Strong teamwork skills; self-motivated; strong work ethics
• Ability to maintain confidentiality