Regulatory Document Specialist at New York

Job Description

Job is located in Tarrytown, NY.

• Responsible for independently formatting and publishing electronic documents for regulatory submissions.
• Integrates and applies strong knowledge of US electronic regulatory submission requirements in support of ongoing drug development programs.
• Independently formats and publishes electronic regulatory submission documents and ensures quality, accuracy, and submission readiness per regulatory agency guidance and specifications.  Will QS others work.
• Develops and maintains document formatting and publishing procedures and standards for regulatory submissions.
• Assists with training other staff on procedures and standards.
• Provides guidance to multidisciplinary teams on format, style, and architecture of electronic compliant documents for INDs, BLAs, MAAs, annual reports, amendments, supplements, or variations in accordance with title 21 CFR and all FDA, EU and ICH guidelines.
• Assists with providing StartingPoint eCTD authoring template training.
• Maintains regulatory archives.
• Provides support and backup to management as needed.

Job Requirements

 

• Bachelors Degree
• 3-5 years experience
• Knowledge of title 21CFR and all FDA and ICH guidelines.
• Prior regulatory document and electronic document publishing experience is required.
• Experience with EU or other international submissions guidelines desired.
• Specialized expertise in formatting and publishing documents.
• Advanced proficiency in use of Microsoft Word, Adobe Acrobat, and electronic document management systems (NextDocs preferred) are required.
• Working knowledge of SharePoint, StartingPoint, ISIToolbox, A-Plus are preferred.

Country: USA, State: New York, City: New York, Company: Joule' Clinical.