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

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