Senior Regulatory Consultant- Lead

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Overview

Senior Regulatory Consultant- Lead - Mexico

Responsibilities

• Creation of regulatory strategies with the client regulatory team to guarantee approval by the Ministry of Health.
• Support in the creation of a high performance team to carry out the necessary activities in the designated project by the client regulatory team.
• 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 product lifecycle.
• Ensure that documents to be submitted to health authorities are ready by ensuring quality review is performed before forwarding to client regulatory personnel.
• Research, draft and assemble the documents required to secure export certificates, market specific product applications / notification and health authority clearances.
• Support for CMC dossier preparation and review.
• Review of artwork changes and associated change controls, including tracking of deliverables.
• Monitoring of new and changing regulatory standards and dissemination of information.
• Support coordination of label change initiation, label reviews and changes in accordance with regional / country review system and procedure.
• Provide regulatory input, review and approval related to change control.
• Support product portfolio through execution of legal document activities as required.
• Coordination with cross functional teams for collating labels and COA's of API, excipients and finished product.
• Coordination with cross functional teams, manufacturing site and local affiliates for the required information to process the documents.
• Search different internal tools for the required information to process the documents.
• Preparation and compilation of regulatory documentation for submission to local country.
• Develop and manage regulatory action item tables for country specific requirements.
• Mapping, coordination of 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 requirements.
• Communicate internally and monitor deliverables ensuring country requirements are met by specified timeframes.
• Record and publish meeting notes. Incorporate follow-up items to project deliverable tracking, ongoing monitoring, and issue escalation to client local managers.
• Manage regulatory action item (task) 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 procedure.
• Complete market impact assessments.
• Generation of databases and checklists for project monitoring.
• Support in the creation of product history and archives.
• Company systems update.

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