Juliana - Regulatory Affairs Professional with 6+ years in Healthcare & Pharma

Managed regulatory dossiers, ensuring compliance with local and international legal requirements.

Prepared and reviewed technical, legal, and regulatory documents for product registrations and updates.

Reviewed and ensured artwork and product dossier accuracy in line with regulatory standards.

Supported translation and interpretation activities between Spanish and English for regulatory purposes.

Review and process requests for corresponding artworks in all countries., Ensure timely delivery of artworks for the Dossier or as required by the Entities., Provide support for new project activities as part of the Company's strategy., Analyze the dossier information sent by the customer and adapt it to comply with current regulations, as applicable, and with renewal, alignment, and improvement schedules. Special projects., Ensure the response to requests from Regulatory Entities and/or the timely delivery of artworks for the Dossier or the Entities' requirements., Review that the Resolutions issued by Regulatory Entities correspond to the requested procedure. When a correction is necessary, submit the request to the Entity., Provide support to other areas of the company, such as preparing PQRs and other required documents., Notify the company's impact areas of the regulatory procedures., Update the SIAR Platform according to the approved procedures., Ensure the legalization of artworks, where applicable.

Review, evaluate, and request justifications for the information submitted by suppliers in the dossier for each product and/or medical device., Evaluate and analyze the requirements made by regulatory entities in each country and generate responses within the stipulated timeframe., Request technical and legal information from product and/or medical device manufacturers in accordance with the requirements of the regulatory entity for each country., Request the corresponding adjustments to the artwork of products submitted to regulatory entities., Review and approve the artwork submitted by the manufacturer for printing on purchase orders for imported and/or domestic products and packaging., Maintain an up-to-date database of current artwork for all authorized products in different countries., Provide support in the feasibility of new products for the growth of the business portfolio., Support in the translation of documents and interpretation meetings from Spanish to English and English to Spanish.