Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

Our science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris’ passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company’s success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other and we believe in respectful, open and honest communications to help support individual and team success.

This position is a temp to hire opportunity, not an immediate direct hire. We are a hybrid work environment with potential for 3 days office/2 days home after successful acclimation period.

Position Summary

RA Publisher is an experienced self-starter who works within the Regulatory Affairs Department and 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 Tris products. The essential responsibilities include, but are not limited to:

• With limited or no supervision, 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
• 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
• 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

QUALIFICATIONS

• Minimum 4 years pharmaceutical industry experience preparing eCTD compliant submissions REQUIRED
• Bachelors degree PREFERRED
• Excellent working knowledge of regulations and guidance as it pertains to format and submission structure REQUIRED
• Proficiency with Acrobat Professional and Microsoft Word and Excel REQUIRED
• Ability to work flexible hours as needed to meet submission deadlines REQUIRED
• Proficiency with PharmaReady publishing tool and ISI Toolbox PREFERRED
• Familiarity with regulatory requirements for Canada and European Union (EU) PREFERRED
• Experience in the use of StartingPoint Templates PREFERRED