Regulatory
Submission Publisher
Responsibilities:
Support regulatory activities for products and marketed product maintenance related to the The product lines include drugs, devices, cosmetics, and other consumer products
Compile electronic- or paper-based-submissions necessary to meet regulatory requirements using available electronic publishing tools
Dispatch electronic submissions through health authority portals
Work with project teams and regulatory project leads to prioritize submission-related activities to deliver contributory submission documents within established timelines
Provide support for data entry, maintenance, and retrieval from computer-based information systems
Disseminate current information related to electronic document management and publishing, to colleagues within the R&D; Consumer organization, and in addition provide them with support, training, and coaching in regard to the appropriate use of electronic information systems relevant R&D; documentation
Responsibilities will also include interaction with the regulatory liaisons with specific product responsibilities, document contributors, and IT System Liaisons within the integral R& D organization




Typical systems that would be used include but are not limited to – Documentum / Connect, docuBRIDGE, Insight Publisher, eValidator, and applicable file-share systems
Deliverables:
Electronic or paper regulatory submission for the regions.
Current information on electronic document management and publishing to CLIENT's Regulatory associates
Training and support to RDO on the appropriate use of electronic information systems for relevant R&D; documentation
Provide support for data entry, maintenance, and retrieval from computer-based information systems
Periodic metrics decks and meetings to evaluate publishing performance
Experience/Qualifications:
Educational Requirements: minimum bachelor's degree in science
Minimum Experience Required: minimum 1 year of experience in the life-sciences industry, preferably in a publishing role
Experience with a variety of computer software and systems. Familiarity with publishing tools preferred
Demonstrate excellent communication skills (English language) – both oral and written
Well-organized and detail-oriented

📌 Regulatory Submission Publisher Consultant (México)
🏢 ClinChoice
📍 México