Senior Regulatory Consultant- Lead

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

Deliverables:

• 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.