Regulatory Operations Technical Consultant (ectd Publishing & Regulatory Systems)

Job description
Technical Consultant, Regulatory Operations (e CTD Publishing \& Regulatory Systems) - RemoteLocation: Mexico (Candidates located in other countries cannot be considered)Work Schedule11:00 AM to 8:00 PM (Mexico Time)This schedule is mandatory due to collaboration with global teams and stakeholders.Ideal candidates currently hold titles such as Regulatory Publishing Specialist, Regulatory Operations Specialist, e CTD Publishing Specialist, Regulatory Systems Specialist, Regulatory Technology Specialist, Submission Management Specialist, or Veeva Vault RIM Specialist.About The RoleParexel is seeking a Technical Consultant 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, e CTD Publishing, Regulatory Technology, or Regulatory Systems Support who enjoy combining technical problem-solving with client-facing consulting responsibilities.What You Will DoRegulatory Systems \& Publishing SupportProvide technical support for regulatory publishing and submission management systems.Troubleshoot issues related to e CTD 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 EngagementPartner 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 \& QualificationsMust-Have Experience3 years of experience in:Regulatory OperationsRegulatory Publishinge CTD Submission ManagementRegulatory Technology SupportRegulatory Information Management (RIM)Experience supporting or using one or more of the following platforms:Veeva Vault RIMDocumentumEXTEDOLorenzCalyx RIMSimilar regulatory publishing or document management systemsStrong understanding of:e CTD submissionsRegulatory publishing processesGlobal regulatory submission standardsSubmission lifecycle managementExperience performing:System troubleshootingSoftware testingValidation activitiesUser supportAdvanced proficiency with:Microsoft Office SuiteAdobe AcrobatWindows operating systemsFluent English communication skills, both written and verbal.Preferred QualificationsBachelor's degree in Life Sciences, Technology, Computer Science, Pharmacy, Regulatory Affairs, or a related field.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 RoleYou 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 e CTD Publishing, Regulatory Operations, Regulatory Systems, Veeva Vault RIM, Documentum, EXTEDO, or Regulatory Technology Support are strongly encouraged to apply.What We OfferOpportunity to work with cutting-edge regulatory technology and publishing systemsExposure to global regulatory standards and best practicesCollaborative, matrix-based environment with opportunities for mentoring and professional developmentDirect client engagement and the ability to drive meaningful business solutionsCompetitive compensation and comprehensive benefits packageParexel is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.#J-18808-Ljbffr