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