Regulatory Documentation Specialist and Compliance

JESSE REYES Port Hueneme, CA Remote 805-***-**** ***********@*****.*** https://www.linkedin.com/in/jessereyesr/

PROFESSIONAL SUMMARY

Regulatory Operations and Document Management professional with 6+ years of experience supporting global pharmaceutical, biotechnology, and healthcare organizations in highly regulated environments. Expertise in regulatory submission support, document lifecycle management, and quality-controlled documentation within Veeva Vault RIM, CDOCS, PromoMats, and enterprise eDMS platforms. Proven track record supporting FDA and global health authority submissions, coordinating high-volume document workflows, improving document review turnaround, ensuring GxP compliance, maintaining regulatory readiness, and supporting audit-ready documentation across regulatory, quality, marketing, and operations teams.

RELEVANT HIGHLIGHTS

Hands-on Veeva Vault PromoMats experience supporting MLR/PRC review processes for the US Marketing MMS business unit at BD.

Managed document review workflows for 25+ marketing stakeholders, coordinating submission and approval of promotional assets through Veeva Vault PromoMats, including 2253 submissions.

Reviewed and validated promotional claims against supporting references to ensure compliance with regulatory and legal requirements.

Generated reporting dashboards and submission status reports for leadership using Veeva reporting tools.

Trained internal and external users on PromoMats workflows, improving submission quality and reducing document revision cycles.

Supported FDA and global health authority submissions, including eCTD components, BLA, NDA, CTA, CMC submissions, IND, international filings, and Health Authority Request for Information responses.

Managed controlled documentation, lifecycle governance, archival, SOPs, work instructions, change requests, CAPA/deviation support, CSV documentation, and regulatory-ready records across Veeva, ETQ, TrackWise, SharePoint, Smartsheet, Jira, and Agile PLM.

CORE SKILLS

Digital Asset Management Lifecycle

Creative Workflow Optimization

Cross-functional Stakeholder Management

Enterprise Document Repository Management

Document Audits

Content Rationalization

Document Governance

Document Ownership

Repository Consolidation

Metadata Management

Document Taxonomy

Version Control

Content Lifecycle Management

Knowledge Management

AI-Ready Documentation

Search Optimization

Content Standardization

Technical Editing

Proofreading

SharePoint

Veeva Vault

ETQ

Document Classification

Process Documentation

PROFESSIONAL EXPERIENCE

AMGEN

Document Management Specialist Remote Sept 2025 – Present

Support enterprise-wide documentation initiatives tied to the SAP S/4HANA transformation program, ensuring GxP documentation aligns with updated system workflows and regulatory compliance requirements.

Audit, author, revise, and maintain 40+ controlled documents supporting enterprise SAP S/4HANA transformation initiatives including design history files, ensuring documentation remains accurate, current, and aligned with evolving business processes in the Veeva RIM document repository.

Track document lifecycle metrics, document ownership, approval status, and repository health using Smartsheet dashboards, improving visibility and governance across enterprise documentation.

Standardize document templates, formatting, and naming conventions to improve consistency and usability across enterprise documentation as well drafting standards.

Partner with cross-functional business stakeholders and subject matter experts to identify documentation gaps, resolve inconsistencies, and improve document quality.

Utilize AI tools, including ChatGPT, to perform document impact assessments and improve documentation clarity and consistency for enterprise knowledge assets.

KIMBERLY-CLARK

Document Management Specialist Remote Nov 2025 - March 2026

Supported the conversion of OTC documents into CSV-relevant templates tied to the SAP S/4HANA program across workstreams including Customer Solutions, Stock to Pay, Warehousing, and Data Management.

•Consolidated and organized enterprise documentation supporting SAP S/4HANA implementation by migrating, uploading, validating, and archiving controlled documents across ETQ and SharePoint.

•Reviewed document completeness, metadata accuracy, approval readiness, and version control prior to migration.

•Standardized documentation to improve consistency across multiple business workstreams.

MOLINA HEALTHCARE

Regulatory Affairs Coordinator Remote Oct 2024 - Dec 2024

Supported regulatory operations within the Strategic Sourcing and Vendor Management - Regulatory Oversight Department, managing vendor regulatory filings and ensuring compliance with state and federal healthcare regulations.

•Managed 10-15 concurrent regulatory vendor filings for Medicare, Medicaid, and Marketplace health plans across multiple states.

•Prepared and submitted regulatory documentation packages to state regulatory agencies, ensuring compliance with regulatory filing requirements and submission deadlines.

•Coordinated cross-functional regulatory submission activities include document gathering, review, and packaging using enterprise content management systems.

•Maintained detailed regulatory filing trackers and documentation inventories to ensure accurate records and audit readiness.

•Conducted regulatory proofreading and validation of submission documentation including ownership disclosures and certification forms.

AMGEN

Document Management Specialist Remote Aug 2023 - Aug 2024

Supported global regulatory operations by managing controlled documentation and submission content within Veeva Vault RIM and CDOCS for regulatory submissions to global health authorities.

•Performed quality control reviews of eCTD submission components, including hyperlink validation, bookmarks, and formatting compliance.

•Supported regulatory publishing activities for BLA, NDA, CTA, and CMC submissions within the Biosimilars Business Unit.

•Led data verification activities supporting responses to Health Authority Requests for Information (RTQs).

•Authored templates supporting similarity sections of regulatory filings, improving submission consistency across documentation packages.

•Initiated and managed deviation investigations within TrackWise, supporting CAPA investigations and compliance remediation.

•Managed CRO document uploads and archival activities within Veeva CDOCS.

BECTON, DICKINSON AND COMPANY (BD)

Senior Specialist - Document Management Control Remote Feb 2022 - Jul 2024

Supported MLR/PRC review processes for the US Marketing MMS business unit, managing marketing promotion asset management and ensuring compliance with FDA regulatory requirements.

•Managed high-volume creative assets through the end-to-end promotional review cycle, ensuring brand consistency and file integrity.

•Reviewed and validated promotional claims against supporting references to ensure compliance with regulatory and legal requirements.

•Generated reporting dashboards and submission status reports for leadership using Veeva reporting tools.

•Trained internal and external users on PromoMats workflows, improving submission quality and reducing document revision cycles.

•Collaborated with CAPA leadership to resolve documentation process gaps and strengthen quality governance practices.

•Served as Showpad administrator, managing controlled document repositories supporting sales enablement teams.

THERMO FISHER SCIENTIFIC

Associate Program Manager Remote Jun 2021 - Apr 2022

Supported global product development and clinical program teams by managing controlled documentation of within Agile PLM and maintaining product development records.

•Managed document change orders and documentation updates supporting product development lifecycle activities.

•Maintained Design History Files (DHF) for In Vitro Diagnostics programs in compliance with quality standards.

•Developed a department training manual that improved documentation quality control and increased process consistency by 30% within two months.

•Maintained document tracking systems and coordinated review workflows across cross functional teams.

EDUCATION

Master of Business Administration (MBA), American InterContinental University Bachelor of Science - Business Management, University of Phoenix

TECHNICAL TOOLS

Veeva Vault (RIM, CDOCS, PromoMats) SAP S/4HANA Agile PLM TrackWise

Smartsheet Jira ETQ Adobe Acrobat Pro / Creative Cloud Microsoft Office (Excel, Word, PowerPoint, Project) SharePoint

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