Technical Consultant – Regulatory Affairs Operation

This is a fully remote position, open to applicants in Mexico.

📋 Description

• Support the team with ongoing systems management tasks while managing customer expectations regarding software functionality, stability, and maintenance.

• Offer advanced troubleshooting for both paper and electronic publishing systems, including PDF, Word, and desktop applications.

• Conduct setup, installation, configuration, testing, and troubleshooting of computer software.

• Document work activities, encompassing system validation, troubleshooting efforts, and internal work requests.

• Execute validation tests for publishing systems in accordance with established documentation and best practices.

• Stay updated on current and upcoming global regulatory submission standards and departmental best practices.

• Prioritize workload and project tasks to meet project scope and objectives.

• Collaborate with clients, internal partners, and software vendors to develop and deliver effective solutions.

• Provide guidance to project team members and mentor junior staff.

• Act as a subject matter expert on significant projects, utilizing past project experience to enhance efficiency.

• Plan and deliver services that ensure client satisfaction and foster relationships for additional business opportunities.

• Facilitate the resolution of technology-related issues in collaboration with project teams and clients.

• Engage professionally across various organizational levels, including senior management within client organizations.

⛳️ Requirements

• Strong knowledge of global regulatory submission formats, industry standards, guidelines, and publishing best practices.

• Proficiency in Microsoft Windows desktop and server environments.

• Advanced proficiency in Microsoft Office products and Adobe Acrobat.

• Practical experience with document management systems (e.g., Documentum, EXTEDO, Lorenz, Calyx RIM, Veeva Vault).

• Fluent in English.

• Advanced troubleshooting techniques for publishing systems and desktop tools.

• Experience in writing and executing validation and quality test scripts.

• Excellent verbal and written communication abilities.

• Capability to manage multiple priorities while maintaining strong attention to detail.

• Client-focused mindset and ability to work efficiently in a matrix environment.

• Flexibility, teamwork orientation, and eagerness to learn new technologies.

• 3-5 years of experience in Regulatory Operations, Publishing, or Regulatory Technology support roles (preferred qualifications).

• Bachelor's degree in Technology, Life Sciences, or a related field (preferred).

• Experience with software validation and quality assurance activities (preferred).

• Proven consulting skills and ability to mentor junior team members (preferred).

🏝️ Benefits

• Opportunity to work with innovative regulatory technology and publishing systems.

• Exposure to global regulatory standards and best practices.

• Collaborative, matrix-based environment offering mentoring and professional development opportunities.

• Direct client engagement with the chance to drive impactful business solutions.

• Competitive compensation and a comprehensive benefits package.