Regulatory Publishing Specialist

Job Title: Regulatory Publishing Specialist Location: Pleasanton, CA 94588 Employment Type: W2 Contract – With Possibility for Extensions Pay Rate: $34.63–$37.63/hour (determined by experience, paid weekly) Work Model: Remote Benefits: Medical, Dental, Vision, and Life Insurance Note: This is a W2 only role — C2C and Corp-to-Corp candidates will not be considered. Role Overview BEPC is actively seeking a detail-oriented Regulatory Publishing Specialist to support our client's Diagnostics Regulatory Affairs team. This remote, part-time position will be responsible for coordinating the preparation, formatting, publishing, and submission of regulatory documentation intended for product registrations, primarily within the U.S. and European Union markets. The ideal candidate will bring at least 5 years of regulatory submission or publishing experience within the diagnostics, pharmaceutical, biotechnology, or life sciences industry. This role requires strong knowledge of regulatory submission requirements, exceptional attention to detail, and proficiency with industry-standard publishing and submission tools. Key Responsibilities Coordinate the preparation, publishing, and submission of regulatory documentation for product registrations, primarily within the U.S. and EU markets. Prepare regulatory submissions in accordance with applicable Health Authority guidelines and internal standards and procedures. Format, publish, and perform quality reviews of regulatory documents to ensure compliance with submission requirements. Collaborate with Regulatory Leads, Managers, project leads, and cross-functional teams to gather required documents and information. Ensure regulatory submission deliverables are complete, accurate, and delivered according to established timelines. Maintain tracking systems to monitor submission status, milestones, deliverables, and deadlines. Support the management and maintenance of regulatory publication databases, repositories, and document management systems. Navigate U.S. Health Authority portals and other regulatory submission systems as required. Coordinate with internal stakeholders to facilitate efficient and timely submission activities. Manage multiple regulatory publishing projects simultaneously while maintaining a high level of accuracy. Maintain organized and compliant regulatory documentation throughout the submission lifecycle. Support compliance with applicable regulatory guidelines, internal procedures, and documentation standards. Required Qualifications Bachelor's degree in Life Sciences, Regulatory Science, Quality, or a related field, or equivalent professional experience. Minimum of 5 years of experience in regulatory submission publishing or a closely related regulatory function . Proven experience preparing compliant regulatory submissions within the diagnostics, pharmaceutical, biotechnology, or life sciences industry. Experience supporting regulatory submissions for the U.S. and/or European Union markets . Familiarity with regulatory guidelines and requirements, including FDA, EMA, ICH, and GxP . Strong understanding of regulatory document preparation, formatting, publishing, and submission processes. Excellent attention to detail and organizational skills. Strong written and verbal communication skills. Ability to manage multiple projects, priorities, and deadlines in a fast-paced environment. Ability to collaborate effectively with Regulatory Affairs professionals, project teams, and cross-functional stakeholders. Technical Skills Microsoft Word Adobe Acrobat Pro ISI Toolbox U.S. Health Authority portals Document Management Systems (DMS) Gmail and Chat Industry-standard regulatory publishing and submission tools Preferred Qualifications Previous experience within a diagnostics, pharmaceutical, or biotechnology organization. Advanced experience with regulatory publishing and submission software. Experience with Veeva RIMS and regulatory document management systems. Experience navigating U.S. Health Authority submission portals.Knowledge of FDA and EU regulatory submission expectations. Demonstrated ability to independently coordinate multiple regulatory publishing deliverables and deadlines. 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. #J-18808-Ljbffr BEPC Inc. - Business Excellence Professional Consulting