Regulatory Operations Specialist
Company: B&H Consulting Services, Inc.
Posted on: January 15, 2023
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;
- 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
- 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
- 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
- Ability to work under deadlines to meet project timelines,
including the ability to have work schedule flexibility.
- 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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