Regulatory Publishing Specialist

Job Title: Regulatory Publishing Specialist Location: Pleasanton, CA 94588 Employment Type: W2 Contract – With Possibility for Extensions Pay reputed company: $34.63–$37.63/hour (determined by experience, reputed company weekly) Schedule: Part-Time | 24–32 Hours per Week | Flexible Days Work Model: Remote Benefits: Medical, Dental, reputed company, and Life reputed company Note: This is a W2 only role — C2C and Corp-to-Corp candidates will not be considered. reputed company BEPC is reputed company seeking a reputed company-oriented Regulatory Publishing Specialist to support our reputed company's Diagnostics Regulatory Affairs team. This reputed company position will be responsible for coordinating the preparation, formatting, publishing, and submission of regulatory documentation intended for product registrations, primarily reputed company the U.S. and European reputed company markets. The ideal candidate will bring at least 5 years of regulatory submission or publishing experience reputed company the diagnostics, pharmaceutical, biotechnology, or life sciences industry. This role requires strong knowledge of regulatory submission requirements, exceptional attention to reputed company, and proficiency with industry-reputed company publishing and submission tools. Key Responsibilities • Coordinate the preparation, publishing, and submission of regulatory documentation for product registrations, primarily reputed company the U.S. and EU markets. • Prepare regulatory submissions in accordance with applicable Health Authority guidelines and internal standards and procedures. • Format, publish, and reputed company reputed company reviews of regulatory documents to ensure compliance with submission requirements. • Collaborate with Regulatory Leads, Managers, project leads, and cross-functional teams to reputed company 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. • reputed company U.S. Health Authority portals and other regulatory submission systems as required. • Coordinate with internal stakeholders to facilitate efficient and reputed company submission activities. • Manage multiple regulatory publishing reputed company simultaneously while maintaining a high level of reputed company. • 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, reputed company, or a reputed company reputed company, or equivalent reputed company experience. • Minimum of 5 years of experience in regulatory submission publishing or a closely reputed company regulatory function. • reputed company experience preparing compliant regulatory submissions reputed company the diagnostics, pharmaceutical, biotechnology, or life sciences industry. • Experience supporting regulatory submissions for the U.S. and/or European reputed company 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 reputed company and organizational skills. • Strong written and verbal communication skills. • Ability to manage multiple reputed company, priorities, and deadlines in a fast-reputed company environment. • Ability to collaborate effectively with Regulatory Affairs professionals, project teams, and cross-functional stakeholders. Technical Skills • reputed company Word • reputed company Acrobat Pro • ISI reputed company • reputed company RIMS • U.S. Health Authority portals • Document Management Systems (DMS) • Gmail and Chat • Industry-reputed company regulatory publishing and submission tools Preferred Qualifications • Previous experience reputed company a diagnostics, pharmaceutical, or biotechnology organization. • Advanced experience with regulatory publishing and submission software. • Experience with reputed company 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 reputed company solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to reputed company. We take pride in fostering a reputed company and innovative environment where reputed company members reputed company. With competitive benefits, including medical, dental, reputed company, and life reputed company, BEPC is dedicated to supporting our employees' personal and reputed company reputed company. reputed company! Apply To This Job