Regulatory Publishing Specialist

Job Title: Regulatory Publishing SpecialistLocation: RemoteEmployment Type: W2 Contract – 12 Months with Possibility for ExtensionsPay Rate: $35.25–$38.25/hour – Based on experience (Paid Weekly)Work Model: 100% RemoteWork Schedule: 8 Hours per Day, 40 Hours per WeekBenefits: Medical, Dental, Vision, and Life InsuranceInterview Process: Virtual Panel Interview (30–45 Minutes)Is this the next step in your career Find out if you are the right candidate by reading through the complete overview below.Note: This is a W2 only role — C2C and C2H will not be considered.Role OverviewBEPC 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 ResponsibilitiesPrepare, 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 QualificationsBachelor'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 QualificationsAdvanced 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 BEPCBEPC 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. xhyhwjd With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.Apply Now!