Regulatory Affairs Manager

Company: Integrated Resources, Inc.
Location: Jersey City
Posted on: May 16, 2022

Job Description:

Job Description
Hours Per Week: 35 hours/ week

Responsibilities

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• Contributes to preparation of high-quality regulatory submissions by helping to organize cross-functional activities pertaining to the regulatory function, including the development of meeting requests, timelines, and compilation of briefing documents intended for submission to regulatory authorities.
  
• Participates and presents in various meetings (e.g., clinical study operation meetings, other regulatory meetings
  
• Works with CROs, reviews and approves regulatory packages. Informs clinical supply for IMP release. Compiles Investigator CV and Form 1572 for FDA submission.
  
• Liaises with external CROs and other vendors to support external safety data processing.
  
• Drafts cover letter and FDA forms for Investigator submissions to FDA.
  
• Ensures compliant documentation is received prior to release of drug supplies.
  
• Ensures compliance and availability of documentation during QA and FDA audits as required.
  
• Provides logistical support preparation for meetings with the FDA/other regulatory agencies.
  
• Stays abreast of industry news through news feeds, publications and industry events and conducts/ analyzes regulatory research to better understand current competitive landscape and trends. Educates internal stakeholders on same.
  
• Provides regulatory support to other MTDA departments and multifunctional teams to ensure compliance with regulatory requirements for content and format of paper/electronic regulatory submissions and documentation.
  
• Independently makes decisions regarding work processes, operational plans or schedules in order to achieve department and project objectives. Escalates more complex issues, as required, to the Associate Director.
  
• Maintains regulatory dossiers in compliance with requirements.
  
• Interacts with global project teams, as required, to ensure the timely preparation and receipt of information required for regulatory submissions in other global regions.
  
• Contributes to process improvement initiatives across the organization.
  
  Qualifications
  
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  • Bachelor's degree in scientific discipline or related field required
    
  • Minimum of 5-7 years of experience in the industry with at least 3-5 years in Regulatory Affairs.
    
  • Experience working in a multicultural, multi-lingual environment.
    
  • In-depth knowledge of the regulatory submissions process and related FDA regulations. Familiarity with international regulatory bodies is a plus.
    
  • Strong organizational skills coupled with a sense of urgency; proven ability to manage processes to timeline.
    
  • Excellent interpersonal and cross-functional collaboration skills.
    
  • Strong attention to detail; a track record of error-free FDA submissions.
    
  • Competency in MS Office (Word, Excel, PowerPoint, Outlook) and Documentum.
    
  • Willingness to engage in light travel (up to 5%).
    
    

Keywords: Integrated Resources, Inc., Jersey City , Regulatory Affairs Manager, Executive , Jersey City, New Jersey