Juana Quevedo

Assess and execute regulatory strategies in South American countries, focusing on Pharmaceutical and Biological products, encompassing products in development, registration, and post-approval maintenance. Offer critical evaluation and support for marketing, sales, and operations concerning marketed products and new projects from a regulatory standpoint.

Engage in innovative strategies to expedite registration processes and analyze the implications of new legislation to comprehend the regulatory landscape.

Guarantee that dossiers adhere to the necessary requirements, thereby minimizing inquiries from health authorities.

Acquired a comprehensive understanding of Global Labelling procedures, including the creation and updates of the CCDS during the life cycle of assigned products, as well as the SmPC text. Contributed to the development and delivery of robust labeling strategies for various countries worldwide, meeting defined deadlines for the products in charge and providing support during the CCDS update implementation process.

Achievement: Successfully collaborated with diverse stakeholders within Medicine, resulting in the timely delivery of labeling strategies and fostering the growth and expansion of my regulatory skill set.

I assessed regulatory changes and devised regulatory strategies in a dynamic regulatory environment. This supported strategic decision-making within the business, ensuring the availability and maintenance of records. Additionally, I participated in pharmaceutical associations to anticipate the introduction of new regulations.

Throughout this experience, I honed my managerial and leadership skills, particularly in leading teams to adapt to the evolving regulatory landscape and achieve our objectives effectively.

responsible for preparing legal and technical documentation for new products, post-registration changes, and renewals in accordance with current legislation in Argentina, adhering to strict deadlines. I developed and presented clear arguments and explanations for Health Authorities' requests, monitored ongoing submissions, and identified potential threats or risks during registration processes, suggesting solutions through the reporting line.

I supported the regional team by providing strategic regulatory input throughout the product life cycle, supplying documentation for local requirements, and offering timelines for the operational execution of these processes. I consistently provided feedback on regulatory strategy to Medical, Marketing, and Operational areas, and supported pharmacovigilance and Product Surveillance processes.

Achievement: Successfully managed multiple product registrations simultaneously, resulting in a 100% on-time submission rate and contributing to the company's ability to launch new products and maintain existing ones in the market.

Global audit and HA inspection with excellent results no major findings.

I prepared submissions for new products, renewals, and activities involving technical changes for Colombia and distributors, ensuring regulatory compliance in accordance with the legislation for each country. I reviewed, analyzed, and approved promotional materials for pharmaceutical products, specifically within the ophthalmology line.

I managed pharmacovigilance activities for Colombia, the Andean region, and Central America, maintaining compliance with the legislation for the assigned countries. I supported quality activities by reviewing new versions of SOPs, reporting technical complaints to the regional quality department, and following up on each case.

I ensured harmonization in labeling for commercialized products across different countries and updated the labeling with the new Company Core Data Sheet.

Achievement: Streamlined the review and approval process for promotional materials, reducing the turnaround , which led to more efficient process, PV Audits successfully performed with no major issues.

I prepared submissions for new medical devices, technical changes, and renewals for commercialized products in Colombia and the Andean region, as well as formulated responses to inquiries from local regulatory agencies. I was responsible for creating a comprehensive database containing regulatory information for medical devices registered in the Andean region, streamlining access to essential data. Additionally, I supported the quality department during internal audits, ensuring compliance with established standards and procedures.