Regulatory Publishing Consultant — Flexible Hours

Quanticate; United States; Remote; USD 70,000 - 95,000; Full time

Benefits offered by this job

Competitive salary

Flexible working hours

Medical Insurance for self and family

Holidays (Annual leave)

Job summary

Quanticate is seeking a Document Specialist (Consultant) to join our team and oversee the formatting, publishing, QC, and redaction of clinical and regulatory documentation for global submissions.

You will collaborate with Medical Writing, Regulatory Affairs, Clinical Operations and cross-functional teams to ensure high-quality, compliant documents with consistent formatting and navigation features. A strong emphasis on accuracy and process improvement is required.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• 3+ years in Regulatory Publishing, Medical Writing Ops, Document Publishing, or Regulatory Operations in pharma/ CRO environments.
• Experience compiling/publishing CSRs and appendices; bookmarks, hyperlinks, cross-references, navigation features.

Responsibilities

• Compile, format, and publish CSRs and appendices per ICH E3 and sponsor requirements.
• Prepare submission-ready PDFs with bookmarks, hyperlinks, and TOCs.
• Publish a variety of clinical/regulatory documents for global submissions.
• Assemble appendices from multiple teams and vendors.
• Ensure consistent formatting and document structure.

Skills

Attention to detail

Planning & prioritisation

Communication skills

Stakeholder management

Problem solving

Independent & collaborative

Education

Bachelor’s degree in Life Sciences

Tools

Adobe Acrobat Pro

Microsoft Word

Document management systems

Job description

Quanticate is seeking a Document Specialist (Consultant) to join our team and oversee the formatting, publishing, QC, and redaction of clinical and regulatory documentation for global submissions.

You will collaborate with Medical Writing, Regulatory Affairs, Clinical Operations and cross-functional teams to ensure high-quality, compliant documents with consistent formatting and navigation features. A strong emphasis on accuracy and process improvement is required.