Posting ID: JP-002027392
IMMEDIATE Regulatory Publisher position looking to start before the new year! Client is a privately held specialty pharmaceutical company leading in research, development, manufacturing and commercialization of both branded products and specialty generic products. They are looking for an experienced candidate to support their team long term and are offering a competitive rate ! Client is looking to interview as soon as this week!
This position 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
Top Skills Details:
Additional Skills & Qualifications:
• Bachelors degree AND 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 PharmaReady publishing tool and ISI Toolbox
• Proficiency with Acrobat Professional and Microsoft Word and Excel
• Ability to work flexible hours as needed to meet submission deadlines
• Familiarity with regulatory requirements for Canada and European Union (EU) PREFERRED
• Experience in the use of StartingPoint Templates PREFERRED
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Jean Chambers
Phone: (410) 579-3072