Regulatory Submission Publishing Specialist

Apollo Professional Solutions; Branchburg Township (NJ); A distancia; USD 55.000 - 103.000; A tiempo parcial

Descripción de la vacante

Apollopros is seeking a Regulatory Submission Publishing Specialist for a remote, contract role in the United States. You will lead end-to-end publishing, validation, and electronic submissions for diverse regulatory filings, including 510(k), PMA, BLA, and IVDR.

The role requires 5+ years in regulatory publishing, strong FDA/EMA/ICH knowledge, and experience with Veeva Vault and eCTD Xpress. Flexible remote work supports global timelines and cross-functional teams.

Formación

• Bachelor's degree in Life Sciences, Regulatory Science, Quality Assurance, or related field.
• 5+ years of experience in regulatory submission publishing within diagnostics or life sciences.
• Strong knowledge of FDA/EMA/ICH submission requirements and electronic submissions.
• Experience with complex publishing processes and project coordination.

Responsabilidades

• Lead end-to-end preparation, publishing, validation, and electronic submission of regulatory dossiers.
• Support submissions including 510(k), PMA, BLA, IND/IDE, IVDR, and global diagnostics filings.
• Publish using Veeva Vault, LORENZ docuBridge FIVE, and eCTD Xpress; manage gateways.
• Coordinate with regulatory teams and external partners to ensure on-time submissions.
• Quality checks, lifecycle planning, traceability, and archival of regulatory documents.

Conocimientos

Regulatory publishing

FDA/EMA knowledge

Project management

Cross-functional collaboration

GxP/quality compliance

Educación

Bachelor's in Life Sciences or Regulatory Science

Advanced degree preferred

Herramientas

Veeva Vault

LORENZ docuBridge FIVE

eCTD Xpress

DMS/CMS regulatory repositories

Descripción del empleo

Regulatory Submission Publishing Specialist (Contract)

Location: Remote

Employment Type: Contract

Advance Global Regulatory Submissions for Innovative Diagnostic Products

Key Responsibilities

Regulatory Publishing & Submission Management

Lead the end-to-end preparation, publishing, validation, and electronic submission of regulatory dossiers.

Support a variety of submission types, including: 510(k) PMA BLA IND IDE IVDR Additional global diagnostic submissions

Ensure submissions meet applicable regulatory requirements, technical standards, and internal quality expectations.

Publishing Systems & Electronic Gateways

Utilize publishing platforms such as Veeva Vault, LORENZ docuBridge FIVE, and eCTD Xpress to compile, validate, and publish submission‑ready documentation.

Manage submission activities through electronic gateways and portals, including: FDA CCP FDA ESG EMA Common Gateway Notified Body submission portals

Monitor submission status, troubleshoot technical issues, and resolve validation errors.

Quality, Compliance & Lifecycle Management

Perform detailed quality control reviews and validation assessments to ensure submission accuracy and completeness.

Manage submission sequencing, lifecycle planning, traceability, and document archiving activities.

Maintain compliance with FDA, EMA, ICH, and other applicable regulatory standards throughout the submission lifecycle.

Adapt publishing practices to evolving regulations and organizational requirements.

Cross-Functional Collaboration

Partner with Regulatory Affairs leaders, commercial affiliates, external vendors, and IT system owners to facilitate efficient submission execution.

Communicate submission readiness requirements and publishing best practices across regulatory teams.

Support issue resolution and process alignment across multiple stakeholders and geographic regions.

Process Improvement & Innovation

Identify opportunities to improve submission workflows, automation, and operational efficiency.

Support implementation of best practices, publishing enhancements, and process standardization initiatives.

Drive adoption of emerging technologies, including artificial intelligence (AI) and robotic process automation (RPA), to improve publishing quality and productivity.

Contribute to strategies supporting new and evolving global regulatory pathways, including reliance‑based approaches.

Required Qualifications

• Bachelor's degree in Life Sciences, Regulatory Science, Quality Assurance, or a related field.
• Advanced degree preferred.
• 5+ years of experience in regulatory submission publishing within diagnostics, medical devices, biotechnology, pharmaceuticals, or related life sciences industries.
• Strong knowledge of FDA, EMA, and ICH regulatory requirements and submission standards.
• Experience managing complex electronic submissions and publishing processes.
• Excellent organization, communication, and project management skills.
• Ability to manage multiple priorities and deadlines independently.
• Experience driving continuous improvement initiatives and workflow optimization.

Preferred Qualifications

• Experience with AI, RPA, or submission publishing automation technologies.
• Familiarity with global regulatory environments beyond the U.S. and Europe.
• Experience with Veeva RIM, document management systems (DMS), content management systems (CMS), and digital regulatory repositories.
• Leadership, mentoring, or coaching experience.

Why Join This Opportunity?

This role offers the opportunity to work remotely while supporting high-impact global regulatory submissions in a collaborative and innovation-focused environment. You'll gain exposure to evolving regulatory requirements, advanced publishing technologies, automation initiatives, and cross-functional partnerships that help bring diagnostic products to market efficiently and compliantly.

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