Senior Regulatory Consultant- Lead job opportunity at ClinChoice.

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ClinChoice Senior Regulatory Consultant- Lead
Experience: 5-years
Pattern: full-time
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Regulatory Affairs

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degreeAssociate
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 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.  

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