GENERAL PURPOSE OF JOB
Assist the Regulatory Affairs department in the preparation, review and submission of various electronic applications to the Food and Drug Administration (FDA) and other regulatory bodies.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Publish submissions (new applications, supplements, amendments, annual reports, etc.) in the proper electronic format and submit to regulatory autorities via the Electronic Submissions Gateway (ESG) or equivalent submission portal utilizing in-house publishing software.
- Prepare documents for submission by scanning, rendering, bookmarking, and hyperlinking.
- Perform quality checks for document integrity and compliance to regulatory standards.
- Troubleshoot document issues and provide guidance to company employees on best practices and regulatory requirements.
- Prepare and maintain electronic templates that will be used company-wide for preparation of submission documents.
- Prepare and submit Structured Product Labeling/Drug Listings to FDA via the Electronic Submissions Gateway (ESG), as required.
- Prepare and submit Establishment Registrations to FDA via the Electronic Submissions Gateway (ESG), as required.
Perform additional Regulatory Affairs duties, as requested.
- Does this job have supervisory responsibilities? No.
- Routine duties are performed with minimal supervision; standard practices or procedures allow the incumbent to proceed alone at routine work; occasional check of work while in progress; work is reviewed upon completion.
- Are there subordinate supervisors reporting to this job position? No.
- Are there other non-supervisory employees who report directly to this job position? No.
OTHER DUTIES AND RESPONSIBILITIES
- Comply with all safety policies, practices and procedures
- Report all unsafe activities to manager and/or Human Resources.
- Participate in proactive team efforts to achieve departmental and company goals.
- Perform other duties as assigned.
EDUCATION AND EXPERIENCE
- Bachelor's degree (B.A. or B.S.) from a four-year college or university and one to two years of experience in electronic submission publishing.
- Experience with document management systems and publishing software (tools) to support paper and electronic submission publishing
- Working knowledge of eCTD structure and requirements
- Proficient with a Windows environment, including SharePoint, Outlook, Word and Excel, and Adobe Acrobat.
- Ability to implement new computer software with minimal supervision.