Title: Regulatory Operations Specialist Start Date: 10/19/2020
End Date: 04/17/2021:
Location: Morris Plains, NJ, United States
Description:
Remote Candidates Will Be Considered.
GENERAL SUMMARY (FUNDAMENTAL PURPOSE OF THE POSITION)
Responsible for formatting and publishing electronic documents, and building of regulatory submission deliverables ensuring submissions are of highest quality and delivered on-time. The position will also archive and track regulatory correspondences, documents and submissions.
ESSENTIAL JOB FUNCTIONS* (PRIMARY RESPONSIBILITIES)
• Electronically formats, publishes electronic documents and builds Regulatory submission deliverables and ensures quality, accuracy, and submission-readiness per Regulatory agency guidance and specifications, and internal procedures.
• Provides guidance on good documentation and submission practices to project teams.
• Archive (categorizing and classifying information) all Regulatory records pertaining to multiple Regulatory Applications (e.g., IND, BLA, CTA), maintaining Regulatory Application indexes, tracking of regulatory submission documents, and special projects as needed.
CORE COMPETENCIES (KNOWLEDGE, SKILLS, AND ABILITIES)
• Good understanding of applicable FDA and ICH guidelines related to regulatory submissions
• Good understanding of eCTD publishing systems, EDMS technology and authoring tools and templates.
• Clear understanding of regulatory submission content and format requirements
• Experienced in lifecycle management eCTD submissions including but not limited to, IND Safety, and IND Investigator submissions
• Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills.
EDUCATION/ EXPERIENCE (MUST INCLUDE MINIMUM REQUIREMENTS NECESSARY TO PERFORM ESSENTIAL JOB FUNCTIONS; ADDITIONAL PREFERENCES OPTIONAL)
• 5-7 years of experience
• BA degree preferred