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Regulatory Operations Specialist

Company: B&H Consulting Services, Inc.
Location: Somerville
Posted on: January 15, 2023

Job Description:

About Us:B&H Consulting Services, Inc., a VCLS company, delivers unsurpassed attention to our client's regulatory needs. The B&H team provides proven regulatory strategy expertise, electronic submission capability, CM&C technical writing support, US/Regulatory Agent services, and effective preparation and coaching for Sponsor/FDA meetings. We are committed to meeting our client's needs. Our broad client list includes large multinational pharmaceutical corporations as well as small, virtual, and biotechnology start-ups.
About the Opportunity: We are currently searching for a Regulatory Operations Specialist in Publishing to work with our team; responsibilities include:

  • Prepare, QC review, and submit pre-and post-approval submissions (IND/CTA/NDA/MAA/NDA, etc.) to the Food and Drug Administration and other Health Authorities, using applicable guidelines and regulations.
  • Perform eCTD readiness/pre-publishing tasks (i.e., formatting and document navigation).
  • Maintain eCTD lifecycle management.
  • Complete high-quality submissions following regulatory guidelines and internal processes within timelines.
  • Understand, interpret and apply Agency regulations and guidelines related to eCTD submissions
  • Ensure knowledge of current eCTD specifications and guidelines.
  • Utilize an array of document management, tracking, publishing, and eCTD building tools.
  • Participate in submission team meetings to plan and track submissions and relevant documents as assigned.
    The ideal candidate will possess the following qualifications:
    Experience/Personal attributes and skills
    • Prior Regulatory Operations experience (eCTD publishing and electronic document processing); experience in a consulting firm is a plus.
    • Degree in a related field is preferred.
    • Highly proficient computer skills including: Electronic submission software (e.g. docuBridge - prior experience a plus), Windows, MS Office (Outlook, Word, Excel, PowerPoint, SharePoint, or similar software), and Adobe.
    • Outstanding work ethic; must be able to perform in a fast-paced, multi-product environment.
    • Responsible, organized, detail-oriented, self-motivated, quick learner, positive attitude, computer savvy.
    • Strong written and verbal communication skills, and possess good interpersonal and team working skills.
    • Problem-solving abilities, adaptability, and a self-starter.
    • Ability to work under deadlines to meet project timelines, including the ability to have work schedule flexibility.
      Additional Information
      • Equal Opportunity Employer
      • All resumes are held in confidence
      • Must be eligible to work in the US

Keywords: B&H Consulting Services, Inc., Somerville , Regulatory Operations Specialist, Other , Somerville, Massachusetts

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