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- 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
📌 Senior Regulatory Consultant- Lead (México)
🏢 ClinChoice
📍 México
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