Documentation Specialist II

Regulatory Document Specialist

Location: Remote

Pay Rate: $ 39.26/hour

Employment Type: Contract

Start Date: ASAP - Earlier than October preferred

Job Summary

We are seeking an experienced Regulatory Document Specialist to support pharmaceutical regulatory submission activities in a fully remote environment. The ideal candidate will have strong hands-on experience with Adobe Acrobat Pro, Veeva RIM, eCTD, regulatory document management, and advanced Microsoft Word formatting .

This position will support document preparation, submission readiness, quality control, electronic document management, and publishing activities across regulatory submissions.

Key Responsibilities

• Create, format, review, and prepare regulatory documents, dossiers, reports, and submission materials for regulatory submissions.

• Prepare documents for eCTD and other electronic submissions , ensuring compliance with applicable regulatory and company requirements.

• Perform submission-readiness validation, including document formatting, consistency, naming conventions, hyperlinks, metadata, and file specifications.

• Conduct detailed quality control and formatting reviews , identifying and correcting errors, inconsistencies, linking issues, and other submission-readiness concerns.

• Manage electronic documents throughout the preparation process, including version control, document tracking, locked documents, embargoes, and document integrity .

• Utilize Veeva RIM and electronic document management systems to organize, maintain, and manage regulatory documents.

• Use Adobe Acrobat Pro extensively for document preparation, manipulation, review, conversion, linking, and quality checks.

• Provide support for document compilation and report publishing across regulatory submission Modules 1-5.

• Collaborate with Regulatory Affairs, Clinical Development, Nonclinical/Research, Quality Assurance, CMC, ITS, and other cross-functional stakeholders.

• Maintain accurate records of document preparation activities, revisions, approvals, and changes.

• Support document migration activities related to acquisitions and organizational changes.

• Monitor evolving regulatory requirements and industry best practices related to electronic submissions and document management.

• Provide guidance and training to internal teams on document preparation, formatting, and submission-readiness requirements.

• Identify opportunities to improve document management and submission-readiness processes and reduce errors.

Required Qualifications

• Bachelor's degree or equivalent degree in Regulatory Affairs, Information Technology, Life Sciences, or a related field; relevant experience may be considered.

• Strong experience in electronic document management within the pharmaceutical or life sciences industry .

• Experience supporting regulatory submissions for clinical trials and registrations, including INDs, CTDs, NDAs, BLAs , or similar submissions.

• Strong experience with Adobe Acrobat Pro .

• Hands-on experience with Veeva RIM or comparable regulatory information/document management systems.

• Strong understanding of eCTD structure and specifications .

• Strong Microsoft Word formatting skills.

• Experience with document preparation and publishing requirements across eCTD Modules 1-5 .

• Understanding of XML tagging, metadata requirements, file formats, naming conventions, and electronic submission specifications.

• Strong attention to detail and ability to perform thorough document quality-control reviews.

• Excellent written and verbal English communication skills.

• Ability to work independently and collaborate effectively with cross-functional teams.

Preferred Experience

• Strong understanding of FDA, EMA, and other applicable regulatory submission requirements.

• Experience with electronic document management systems (EDMS).

• Experience troubleshooting document formatting, conversion, hyperlinking, and submission-readiness issues.

• Knowledge of regulatory processes throughout different stages of drug development.

• Experience providing training or support to colleagues regarding document management and submission requirements.

• Familiarity with current regulatory intelligence, industry standards, and electronic submission best practices.

Key Skills

Adobe Acrobat Pro | Veeva RIM | eCTD | Regulatory Submissions | Document Management | Microsoft Word | Document Formatting | Report Publishing | Submission Readiness | Quality Control | Version Control | Metadata | XML | EDMS | FDA/EMA Regulations | Pharmaceutical Industry

Compensation & Work Arrangement

Pay Rate: $39.26 per hour

Work Arrangement: 100% Remote

Start: ASAP; candidates available to start before October are preferred.

Pay Details: $39.26 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act

• Los Angeles City Fair Chance Ordinance

• Los Angeles County Fair Chance Ordinance for Employers

• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.