Senior Regulatory Consultant- Lead

Senior Regulatory Consultant – Lead – Mexico Lead the team of consultants to meet the project objectives and oversee the creation of regulatory strategies with the client regulatory team to ensure approval by the Ministry of Health. Responsibilities Lead the team of consultants to meet the project objectives. Preparation, compilation, and coordination of high‑quality regulatory submissions for new product launches, product updates, and throughout the product lifecycle. Ensure that documents to be submitted to health authorities are ready by performing quality reviews before forwarding to client regulatory personnel. Research, draft, and assemble the documents required to secure export certificates, market‑specific product applications/notifications, and health authority clearances. Support CMC dossier preparation and review. Review artwork changes and associated change controls, including tracking of deliverables. Monitor new and changing regulatory standards and disseminate information. Coordinate label change initiation, label reviews, and changes in accordance with regional/country review systems and procedures. Provide regulatory input, review, and approval related to change control. Support product portfolio through execution of legal document activities as required. Coordinate with cross‑functional teams to collate labels and COAs for API, excipients, and finished product. Coordinate with manufacturing site and local affiliates for the required information to process documents. Search internal tools for the required information to process documents. Prepare and compile regulatory documentation for submission to local countries. Develop and manage regulatory action‑item tables for country‑specific requirements. Map, coordinate regulatory inputs and timing end‑to‑end for country requirements resulting from legal entity change (e.g., documentation required, timelines for registrations/notifications, and phase‑in of changes to meet compliance). Communicate internally and monitor deliverables to ensure country requirements are met by specified timeframes. Record and publish meeting notes. Incorporate follow‑up items into project deliverable tracking, ongoing monitoring, and issue escalation to client local managers. Manage regulatory action‑item tables, including mapping, coordination of regulatory inputs, and timing. Work with client regulatory managers to develop project implementation plans and manage workload planning to ensure on‑time completion of projects and tasks. Support client regulatory managers in their registration procedures. Complete market impact assessments. Generate databases and checklists for project monitoring. Support in the creation of product history and archives. Deliver weekly updates to relevant client regulatory managers. Ensure regulatory standards and timelines are met. Plan and track the status of ongoing regulatory projects. Create presentation materials for management updates. Ensure documents for health authority are submission‑ready. Qualifications Regulatory professional with formal college or higher education in a science‑related discipline. Minimum 5+ years of relevant work experience in regulatory affairs. Fluency in English and the local language. Good understanding of local regulations for OTC, cosmetics, and medical devices. Strong working knowledge of Microsoft Word, Excel, and PowerPoint. Good communication and follow‑up skills with country regulatory liaisons to understand country‑specific needs for registrations, license updates, and import/export requirements. Seniority level: Mid‑Senior levelEmployment type: Full‑timeJob function: LegalIndustries: Pharmaceutical Manufacturing #J-18808-Ljbffr