Regulatory Publishing Consultant (Regulatory Systems SME)

Job summary

Provide technical support, troubleshooting, configuration, testing, and validation for regulatory publishing systems and submission tools. Advise clients and internal teams on regulatory technologies, resolve technical challenges, and support project teams through recommendations and mentoring.

Job details

My research opens up new medical possibilities. And I do it Search Jobs Search Jobs Keyword Matching job links will appear below as you type. Location: When autocomplete results are available use up and down arrows to review and enter to select. Touch device users, explore by touch or with swipe gestures. Radius: Enter distance 5 15 25 35 50 Unit MILES KM View Remote Jobs View All Jobs View remote jobs View all jobs Regulatory Publishing Consultant (Regulatory Systems SME) Primary Location: Canada, British Columbia, Remote Job ID R0000046923 Category Administrative Apply Now About This Role About Parexel Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere. We work with focus, agility, and shared purpose -- moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart(R). About The Role Parexel is seeking a Regulatory Publishing Consultant (Regulatory Systems SME) to join our Regulatory Operations team. In this role, you will serve as a subject matter expert for regulatory publishing systems, document management technologies, and electronic submission tools used to support global regulatory activities. You will partner with internal teams, software vendors, and external clients to provide technical support, troubleshoot complex issues, execute validation activities, and ensure the effective use of publishing and regulatory information management solutions. This position is ideal for professionals with experience in Regulatory Operations, eCTD Publishing, Regulatory Technology, or Regulatory Systems Support who enjoy combining technical problem-solving with client-facing consulting responsibilities. What You Will Do Regulatory Systems & Publishing Support Provide technical support for regulatory publishing and submission management systems. Troubleshoot issues related to eCTD publishing tools, document management systems, PDF creation, Microsoft Office applications, and desktop environments. Configure, install, test, validate, and maintain regulatory technology solutions. Support system validation activities, execute test scripts, and document results. Maintain compliance with regulatory submission standards, publishing guidelines, and industry best practices. Manage multiple priorities while ensuring high-quality deliverables and service levels. Consulting & Client Engagement Partner with clients, regulatory teams, and software vendors to resolve technical challenges and deliver effective solutions. Act as a trusted advisor on publishing technologies and regulatory systems. Support project teams by sharing expertise and mentoring less experienced team members. Participate in client meetings and provide recommendations to improve efficiency and system utilization. Build strong relationships with internal and external stakeholders while ensuring client satisfaction. Required Experience & Qualifications Must-Have Experience 3+ years of experience in: Regulatory Operations Regulatory Publishing eCTD Submission Management Regulatory Technology Support Regulatory Information Management (RIM) Experience supporting or using one or more of the following platforms: Veeva Vault RIM Documentum EXTEDO Lorenz Calyx RIM Similar regulatory publishing or document management systems Strong understanding of: eCTD submissions Regulatory publishing processes Global regulatory submission standards Submission lifecycle management Experience performing: System troubleshooting Software testing Validation activities User support Advanced proficiency with: Microsoft Office Suite Adobe Acrobat Windows operating systems Fluent English communication skills, both written and verbal. Bachelor's degree in Life Sciences, Technology, Computer Science, Pharmacy, Regulatory Affairs, or a related field. Due to the global nature of our team, this role requires the ability to work from 2pm ET-10pm ET Preferred Qualifications Experience writing and executing validation protocols and test scripts. Experience working within a CRO, pharmaceutical, biotechnology, or regulatory technology environment. Prior client-facing or consulting experience. Experience mentoring team members or acting as a subject matter expert. Success in This Role You will be successful if you have hands-on experience with regulatory publishing technologies and enjoy solving technical challenges while working closely with clients and cross-functional teams. Candidates with backgrounds in eCTD Publishing, Regulatory Operations, Regulatory Systems, Veeva Vault RIM, Documentum, EXTEDO, or Regulatory Technology Support are strongly encouraged to apply. What We Offer Opportunity to work with cutting-edge regulatory technology and publishing systems Exposure to global regulatory standards and best practices Collaborative, matrix-based environment with opportunities for mentoring and professional development Direct client engagement and the ability to drive meaningful business solutions Competitive compensation and comprehensive benefits package If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply! We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research. Apply Now Share this Page X Facebook LinkedIn Email Inclusion at Parexel Learn how Parexel celebrates the differences our workforce and patients bring and ensures an inclusive environment. Learn more New Medicines, Novel Insights Newsletter Parexel's insight-generation engine, our people, share perspectives on patient-guided clinical research. Learn more Working where it works for you Parexel offers a flexible approach to work that meets your personal needs while maintaining quality delivery for patients. Choose the right work arrangement for you - in-office, home-based or a mix. Learn more Benefits & Support At Parexel, we prioritize putting people first, allowing you to achieve your best work. Explore the Flexible Work Program, our "Bravo" Recognition Program, and how we build our well-being in our supportive culture. Learn more Parexel’s hiring process It’s all about finding the right fit, for you and for us. Our recruiters work with you and our hiring managers to bring together a team and culture where everyone can grow and be successful. Learn more Our work culture Learn about our culture, perks, learning opportunities, and our corporate responsibility approach. Parexel's compassionate and results-driven work culture prioritizes patient care and employee growth. Learn more JOBS FOR YOU Regulatory Publishing Consultant (Regulatory Systems SME) Canada, Remote Executive Director, Corporate Real Estate Services Raleigh, United States of America Site Contracts Associate I/II - GERMAN LANGUAGE REQUIRED Serbia, Remote View All Jobs There is no jobs to view You currently have no saved jobs to view. Make sure to accept the Functional cookies to enable this module to display saved job links. You will be able to review them here when you revisit this page.. View Open Positions More Than A Job Benefits Benefits vary by country, but Parexel is passionate about our team’s overall wellness. Learn More Career Advancement We believe that investing in your professional and personal development is an investment in Parexel, and we want to help you realize your full potential and career. Learn More

What you’ll do

Provide technical support, troubleshooting, configuration, testing, and validation for regulatory publishing systems and submission tools. Advise clients and internal teams on regulatory technologies, resolve technical challenges, and support project teams through recommendations and mentoring.

Requirements

Requires at least three years of experience in regulatory operations, publishing, eCTD submissions, regulatory technology support, or regulatory information management, along with experience using a regulatory platform such as Veeva Vault RIM, Documentum, EXTEDO, Lorenz, or Calyx RIM. Candidates need a relevant bachelor's degree, strong knowledge of eCTD processes and global submission standards, technical troubleshooting and validation experience, advanced Microsoft Office, Adobe Acrobat, and Windows skills, fluent English, and availability to work 2 p.m.–10 p.m. ET.

Benefits

• Competitive Compensation
• Comprehensive Benefits Package
• Flexible Work Program
• Recognition Program
• Professional Development

Listed skills

• Microsoft Office · Preferred
• Technical Support · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Regulatory Operations
• Regulatory Publishing
• eCTD Submission Management
• Regulatory Technology Support
• Regulatory Information Management
• System Troubleshooting
• Software Testing
• System Validation
• Microsoft Office
• Adobe Acrobat
• Windows Operating Systems
• Client Consulting
• Technical Support
• Document Management Systems
• Stakeholder Engagement
• Mentoring

Job areas

• Administrative
• Technology
• Healthcare
• Consulting

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