Title: Regulatory Publishing Manager

Location: Menlo Park, CA

Forty Seven Inc. is committed to helping patients defeat their cancer. We are advancing immune-oncology through the engagement of new and complementary phagocytic pathways that enhance anti-tumor efficacy and selectivity

 

Summary:
This position is contract to full-time hire for tasks related to the publishing of regulatory documents to provide submission support to project teams. The focus of the position will be to publish, submit and maintain regulatory filings according to applicable FDA and international requirements, eCTD backbone file specifications and in coordination with Regulatory Affairs department standards, as applicable.

 

Essenial Functions:

  • Responsible for pre-publishing and publishing, of regulatory documents in paper and/or electronic formats.
  • Use existing or new customized word templates for pre-publishing regulatory documents
  • Ensure documents are formatted per company style guide 
  • Maintain current knowledge of global standards, and procedures for regulatory submissions publishing
  • Provide advanced MS word processing support that includes trouble shooting issues for regulatory technical documents 
  • Provide advanced PDF processing/editing support using Adobe Acrobat or Acrobat Plug-in tools
  • Compile various routine and non-routine submissions such as INDs (safety reports, investigator information, protocol amendments, etc.), NDAs (original submissions, supplements, responses)
  • Archive submission receipts per existing standards
  • Ability to troubleshoot and resolve validation errors while publishing
  • Dispatch submissions through the FDA Gateway
  • Coordinate with assigned submission contributors while planning, preparation, and publishing regulatory submissions
  • Maintain/Update chronological log for regulatory submission and Agency correspondence
  • Share ideas for process improvement and communicate industry best practices
  • Ensure that issues are identified at an early date and actively contribute to issue resolution before filing dates are impacted
  • Adhere to relevant SOPs and work in compliance with regulatory standards
  • Perform Other duties as needed

 

Education & Experiance:

  • Bachelor’s degree desired or equivalent relevant professional experience in Regulatory Publishing/Operations
  • A minimum 1-3 years related experience in publishing/Regulatory Operations in the biotechnology or pharmaceutical industries
  • Basic understanding of the US, EU, and ICH publishing regulations and guidelines.
  • Excellent computer skills, including proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Office) and PDF plug-in tools, Adobe Acrobat
  • Proficiency in publishing regulatory documents and using regulatory e-submission software e-Submitter, FDA validation software, especially Global submit, SharePoint and others as necessary
  • Previous hands-on experience with compiling documents for routine IND, NDAs, Amendments, Supplements submissions in paper and eCTD format
  • Proficiency in scanning and standard graphics software
  • Ability to work independently with minimal supervision
  • Strong verbal and written communication skills
  • Ability to multi-task, pay close attention to detail, and follow projects through to completion
  • Excellent organizational, prioritization, and planning skills
  • Must have excellent verbal, written, interpersonal, and communication skills
  • Exemplary organizational and time management skills, and able to work in a fast-paced and dynamic environment.
  • Strong working knowledge of cGMP, FDA/EMA regulations and ICH guidelines

 

Other Qualifications:

  • Must be detail oriented with well-developed organizational and analytical skills
  • Must enjoy working in a fast-paced, small company environment with proven ability to be flexible and adaptable within a changing dynamic environment

 

Apply Now