Regulatory Document Formatting Lead — Remote

Regulatory Jobs; San Carlos (CA); Hybrid; USD 112,000 - 131,000; Full time

Job summary

Vaxcyte, a clinical-stage vaccine company, seeks a Senior Regulatory Document Formatting Specialist in Regulatory Operations. You will format and finalize complex regulatory documents, ensure templates/CTD alignment, and support submission planning for health authorities.

This role emphasizes attention to detail and collaborative cross-functional work. Based in San Carlos, CA or remote with a hybrid arrangement, candidates should have 5+ years in Regulatory Operations and strong Word/Adobe

Qualifications

• College degree (AA/AS or BA/BS) in a related field required.
• Minimum 5 years of Regulatory Operations experience with formatting/word processing regulatory documents.
• Experience formatting complex documents and using internal templates and style guides.

Responsibilities

• Format and finalize documents for regulatory submissions using Word and templates.
• Maintain literature lists and ensure accurate citations within CTD documents.
• Collaborate with Regulatory team and other functions to meet submission timelines.
• Support submission planning, preparation, and review activities.
• Assist in implementing and improving regulatory systems, processes and tools.

Skills

Regulatory operations

Attention to detail

Time management

Education

AA/AS or BA/BS in a related field

Tools

Word

Excel

PowerPoint

Adobe Acrobat Pro

Veeva RIM

OmniTemplates

Job description

Vaxcyte, a clinical-stage vaccine company, seeks a Senior Regulatory Document Formatting Specialist in Regulatory Operations. You will format and finalize complex regulatory documents, ensure templates/CTD alignment, and support submission planning for health authorities.

This role emphasizes attention to detail and collaborative cross-functional work. Based in San Carlos, CA or remote with a hybrid arrangement, candidates should have 5+ years in Regulatory Operations and strong Word/Adobe