Sr. Regulatory Document Formatting Specialist

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

Join our Mission to Protect Humankind!

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

WHATwe do is every bit as important asHOWwe do it!Our work together is guided by four enduring core values:

*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.

*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.

*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.

*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

Summary:

The Senior Regulatory Document Formatting Specialist, in Regulatory Operations, will format and finalize documents for regulatory submissions. The ideal candidate will have experience formatting complex documents, in-depth understanding of Microsoft Word and Adobe Acrobat Pro, and experience with using document templates. This role will assist with regulatory submission planning, preparation, and review to ensure high quality, timely submission of regulatory filings to health authorities.

Essential Functions:

Ideal candidates should be able to produce high quality documents within established time frames. Job activities include:

• Formatting and compiling documents using Word to create and update tables of contents, add headers/footers and table and figure titles, insert figures, create bookmarks and links, split multiple-page tables, use track changes and comment functions.
• Working in a collaborative authoring environment (Veeva RIM).
• Reviewing documents to ensure that formatting is consistent throughout documents in accordance with internal templates and style guide (use of abbreviations, in-text citations, hyperlinks, terminology, bibliographies, etc.).
• Maintaining the list of literature for regulatory submissions and obtaining copies of literature, as needed.
• Communicating effectively with the Regulatory team and other functional groups, as needed, to meet project timelines.
• Assisting with Regulatory Operations’ efforts to implement and improve systems, processes, and tools.

Requirements:

College degree, AA/AS or BA/BS with a minimum of 5 years of experience in Regulatory Operations with formatting/word processing regulatory documents. Other combinations of education and/or experience may be considered.

• Proficient with Word, Adobe Acrobat Pro, PowerPoint, and excel.
• Familiar with using Veeva RIM for authoring and reviewing documents is preferred.
• Experience with using OmniTemplates is a plus.
• Good understanding of the CTD structure and Clinical documents (Protocols, Clinical Study Reports, Statistical Analysis Plans, etc.) in accordance with regulatory guidelines
• Accustomed to fast-paced, highly regulated environment with the ability to work independently.
• Accountable, adaptable, and dependable.
• Sound business ethics, including the protection of proprietary and confidential information, is required.
• Excellent attention to detail and organizational/time-management skills.
• Works well with others.

Reports to:

Manager, Regulatory Operations

Location:

San Carlos, CA or Remote

Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy):

Hybrid (minimum of 2-3 days per week onsite) or Remote

Compensation:

The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range:

$112,000 – $131,000 (SF Bay Area). Salary ranges for non-California locations may vary.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.