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.