Regulatory Affairs Publisher
- Location: Middlesex County, NJ
- Type: Contract To Hire
- Job #38103
Seeking a Regulatory Affairs Publisher for our client, a leading biopharmaceutical company.
This role is accountable for all publishing, verification, dispatch and management of Electronic Common Technical Documents (eCTDs) compliant submission dossiers for all investigational, marketing authorization, lifecycle management and post approval changes supporting products.
- Responsible for all stages of submission management including, but not limited to: document preparation, scanning, rendering, bookmarking, hyperlinking, troubleshooting document issues and performance of quality checks of documentation and final validation
- Ensure submission of high-quality eCTD compliant dossiers that are in conformance with applicable regulatory guidelines for Investigational New Drugs (INDs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs) and Drug Master File (DMF) submissions
- Provides regulatory submission leadership, support and guidance to cross-functional teams to ensure requirements are met and incorporated into all documentation included in eCTD submissions and holds team members accountable to deliver documentation that is submission ready
- Builds submissions by generating the XML backbone and populate leaf files for submissions in addition to associated activities identified above
- Prepares new Standard Operating Procedures (SOPs), manages document templates, trains personnel on use of authoring tools and identification of regulatory submission process improvements
- Maintains Regulatory Affairs paper and electronic files including submission chronologies
- Bachelors degree strongly preferred
- Minimum 4 years pharmaceutical industry experience preparing eCTD compliant submissions
- Excellent working knowledge of regulations and guidance as it pertains to format and submission structure
- Proficiency with Acrobat Professional and Microsoft Word and Excel