Regulatory Publishing Specialist

BEPC Inc. - Business Excellence Professional Consulting; Branchburg Township (NJ); Remote; USD 49,000 - 53,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Job summary

BEPC Inc. seeks a Regulatory Publishing Specialist for a fully remote, W2 contract role (12 months, extensions possible). The candidate will manage regulatory dossiers for diagnostic products, support 510(k)/PMA/BLA/IND/IDE/IVDR/eCTD submissions, and coordinate with FDA/EMA portals.

Proficiency with Veeva Vault, LORENZ docuBridge, or eCTD Xpress is essential. The ideal candidate has 5+ years in regulatory publishing, strong FDA/EMA knowledge, and collaborative skills across cross-functional

Qualifications

• Minimum 5 years of regulatory submission publishing experience.
• Strong understanding of FDA, EMA, and ICH regulatory standards.
• Experience with electronic regulatory submissions and publishing platforms.

Responsibilities

• Prepare, compile, publish, and submit electronic regulatory dossiers for diagnostic products.
• Support regulatory submission types (510(k), PMA, BLA, IND, IDE, IVDR, eCTD).
• Use publishing platforms such as Veeva Vault, LORENZ docuBridge FIVE, and eCTD Xpress.
• Manage submissions through FDA CCP, FDA ESG, EMA gateways, and Notified Body portals.
• Perform submission validation, QC, and compliance checks.
• Review validation reports and troubleshoot publishing errors.
• Coordinate submission lifecycle, sequencing, and timelines.
• Maintain regulatory documentation repositories (Veeva RIM/DMS/CMS).
• Ensure compliance with FDA/EMA/ICH and global requirements.
• Collaborate with Regulatory Affairs, IT, and external vendors.
• Maintain submission traceability and audit-ready records.
• Identify opportunities for process improvement and automation.

Skills

Regulatory knowledge

Attention to detail

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in Life Sciences/Regulatory Science

Advanced degree preferred

Tools

Veeva Vault

LORENZ docuBridge FIVE

eCTD Xpress

FDA CCP

FDA ESG

EMA portals

DMS/CMS

Job description

Job Title: Regulatory Publishing Specialist

Location: Remote

Employment Type: W2 Contract – 12 Months with Possibility for Extensions

Pay Rate: $35.25–$38.25/hour – Based on experience (Paid Weekly)

Work Model: 100% Remote

Benefits: Medical, Dental, Vision, and Life Insurance

Note: This is a W2 only role — C2C and C2H will not be considered.

BEPC is seeking an experienced Regulatory Publishing Specialist to support our client's Diagnostics Regulatory Affairs team in a fully remote position.

This role focuses on regulatory submission publishing, electronic dossier preparation, submission validation, and global regulatory compliance for diagnostic products, primarily supporting the U.S. and European markets.

The ideal candidate has 5+ years of regulatory submission publishing experience, strong knowledge of FDA and EMA requirements, and expertise with regulatory publishing platforms such as Veeva Vault, LORENZ docuBridge, or eCTD Xpress.

Key Responsibilities

• Prepare, compile, publish, and submit electronic regulatory dossiers for diagnostic products.
• Support regulatory submission types, including 510(k), PMA, BLA, IND, IDE, IVDR, and eCTD submissions.
• Use regulatory publishing platforms such as Veeva Vault, LORENZ docuBridge FIVE, and eCTD Xpress.
• Manage electronic submissions through FDA CCP, FDA ESG, EMA Common Gateway, and Notified Body portals.
• Perform submission validation, quality control, and compliance checks to ensure accuracy and completeness.
• Review validation reports, troubleshoot publishing errors, and resolve submission issues.
• Coordinate submission lifecycle management, sequence planning, and regulatory timelines.
• Maintain regulatory documentation and repositories using Veeva RIM, DMS, CMS, and related systems.
• Ensure compliance with FDA, EMA, ICH, and applicable global regulatory requirements.
• Collaborate with Regulatory Affairs, IT, commercial affiliates, and external vendors.
• Maintain submission traceability, document integrity, and audit-ready records.
• Identify opportunities for process improvement, automation, AI, and robotic process automation (RPA).
• Support implementation of emerging regulatory requirements and global submission processes.

Required Qualifications

• Bachelor's degree in Life Sciences, Regulatory Science, Quality Assurance, or a related field.
• Minimum 5 years of experience in regulatory submission publishing within diagnostics or related life sciences industries.
• Strong understanding of FDA, EMA, and ICH regulatory standards.
• Experience preparing, publishing, validating, and managing electronic regulatory submissions.
• Knowledge of regulatory publishing tools and electronic submission gateways.
• Familiarity with regulatory document management, submission lifecycle management, and quality control.
• Excellent organizational skills and ability to manage multiple deadlines independently.
• Strong attention to detail, accuracy, and regulatory compliance.
• Excellent written and verbal communication skills.
• Ability to collaborate effectively with cross-functional and geographically distributed teams.
• Experience supporting continuous improvement and process automation initiatives.

Preferred Qualifications

• Advanced degree in Life Sciences, Regulatory Science, Quality Assurance, or a related discipline.
• Hands-on experience with Veeva Vault, LORENZ docuBridge FIVE, or eCTD Xpress.
• Experience with FDA CCP, ESG, EMA Common Gateway, or Notified Body submission portals.
• Familiarity with Veeva RIM, DMS, CMS, and regulatory document repositories.
• Experience implementing AI, robotic process automation (RPA), or regulatory publishing automation tools.
• Knowledge of global regulatory requirements beyond the United States and European Union.
• Previous experience in team leadership, mentoring, or regulatory publishing process improvement.

About BEPC

BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.