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Position Summary: Responsible for regulatory management of products, regulatory compliance, coordination with manufacturers and authorities, and support to distributors, ensuring timely updating and organization of information. Key Responsibilities: 1. Comprehensive management of post-registration requirements and product updates. 2. Maintenance and organization of regulatory databases. 3. Regulatory support to distributors in the ARC Sub-Region. 5\. Continuously review information related to regulations or legislation impacting the activities of one or more areas within the organization, in order to disseminate identified modifications or updates to the relevant areas (via email), verifying whether procedure updates are required and implementing or requesting such updates as appropriate. 6\. Continuously coordinate with manufacturers regarding the implementation of changes, updates, expansions, discontinuations, and other authorized procedures via the virtual channel, to anticipate organizational needs, keep registrations up to date, and identify inconsistencies. 7\. Submit applications to the competent authority according to the procedures corresponding to the role, conducting follow-up to obtain approval of such procedures, thereby keeping the regulatory information database current, organized, and updated. 8\. Maintain regional and local organizational regulatory databases up to date to ensure accurate control and recordkeeping. 9\. Support the team handling inspections, audits, and certifications by consolidating and supplying required information, to successfully pass inspections or audits and achieve required certifications. 10\. Organize and update the regulatory information database, safeguarding documentation under the department’s responsibility to provide required information during internal or external audits (conducted by the regulatory authority either on a scheduled or unannounced basis). 11\. Perform translations of manufacturer documents or review such translations (when outsourced to third parties) to submit Spanish-language information required by DIGEMID for reviewing procedures related to the role. 1\. Manage post-registration requirements (preparation of files and documentation for change requests, updates, expansions, discontinuations, authorizations, and other applications) related to registered products, requesting relevant information from manufacturers, analyzing and consolidating such information, and submitting it to DIGEMID while indicating identified variations, with the objective of requesting and obtaining registration updates. 2\. Conduct required inquiries regarding company products before competent authorities to align knowledge. 3\. Provide regulatory procedural support to distributors in Paraguay, Uruguay, and Bolivia (ARC Sub-Region) to channel their requirements to manufacturers, assisting in the registration and updating of products offered by each distributor with the respective national regulatory authorities. 4\. Provide the ARC Sub-Region and other departments upon request with documentary information related to regulatory matters and certifications, to ensure proper dissemination of information and meet the documentation needs of each requester.
