Senior Regulatory Consultant- Lead Mexico

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 monitoring 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

Provision of weekly updates (at a minimum) to relevant client regulatory managers

Ensure regulatory standards and timelines are met

Plan and track the status of ongoing regulatory projects

Regulatory action item tables for country specific requirements and importation / exportation needs for change in legal entity

Presentation materials for management updates

Ensuring documents for health authority are submission-ready

Supporting coordination of label change initiation, label reviews and changes in accordance with regional / country review system and procedure.

Regulatory input, review and approval related to Change Control

Experience / Qualifications :

Regulatory professional with formal college or higher education in science related discipline

Relevant work experience with minimum 5+ years in regulatory affairs

Individuals must have fluency of English and local language.

Good understanding of local regulations for OTC,Cosmetics and Medical devices

Strong working knowledge of Microsoft Word, Excel, Power Point

Good communication and follow up skills with country regulatory liaisons for clear understanding of country specific needs for registrations, license updates and import / export requirements.

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