Job Description: Regulatory Document Specialist (Editor/QC/Submissions) (Remote and Full Time)

At Facet, our mission is to make life sciences dreams a reality. We are regulatory and development leaders with a passion for helping small organizations expedite innovative products to and through FDA to patients in need. We are a small company with big company benefits, including health, dental, life, supplemental, and disability insurance; a 401K program; bonus programs; company-supported annual training; a flexible work environment; and unlimited sick and vacation time.

Role description:

The Document Specialist helps emerging life science companies advance their drug, biologic, device, or combination products by editing, performing quality control (QC) on, and finalizing clinical, nonclinical, and CMC documents for submission to FDA. The role works independently and collaborates closely with Facet writers, regulatory strategists, and clients. Success requires exceptional attention to detail, flexibility, willingness to learn, clear communication, and the ability to manage multiple documents and deadlines without compromising quality. Potential for career development into broader regulatory affairs space or medical writing. Applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status.

Key Responsibilities:

• Edit and proofread regulatory documents for IND, NDA/BLA, DMF, 510(k), and PMA submissions (spelling, grammar, and punctuation; ensure consistency of terminology, and abbreviations).
• QC text, tables, and figures against source documentation, verify references and citations, and coordinate resolution of issues with authors and clients.
• Format MS Word and PowerPoint documents to template and style guide, produce eCTD-compliant PDFs including bookmarking and linking, and coordinate publishing with internal teams and vendors.
• Prepare eCTD-compliant submission builds, manage documents, and assist in creating and maintaining submission trackers.
• Maintain timelines and work within the assigned contract budget for editing and QC assignments.
• Be familiar and work in accordance with US Federal Regulations, FDA eCTD guidance, ICH guidelines, and Facet SOPs.
• Contribute to the development and maintenance of Facet and departmental working practices and procedure.

Experience and Skills Desired:

• Bachelor’s degree required; advanced scientific degree (e.g., MS, Ph.D.) preferred.
• At least 2 years of regulatory document editing/QC experience required.
• Working knowledge of eCTD structure and FDA electronic submission requirements (21 CFR Part 11).
• IND, NDA, or BLA submission and eCTD experience strongly preferred.
• Expert in MS Word (including templates, styles, and advanced formatting), Excel, PowerPoint, and Adobe Acrobat.
• Exceptional attention to detail and strong organizational and time management skills.

Salary range: $100,000 to $130.000 USD, depending on qualifications and experience.

Have questions? Contact Eva Raspor at eva.raspor@facetls.com.