Karen Vargas

With complementary university training in legislation, safety and efficacy of cosmetic products, validation of methodologies and drug stability. With experience in pharmaceutical regulation, developing competencies in the evaluation and regulatory compliance of pharmaceutical products for Colombia and Latam, familiar with the updated regulations of Decree 334 of 2022 and Decree 1474 of 2023, as well as the current regulation in the Andean Community (CAN) for cosmetics according to Decision 833 of 2018. I stand out for my adaptability, organization and autonomy, combined with a constant concern for acquiring new knowledge and keeping myself professionally updated.

Regulatory Affairs Intern Vitalis, February 2024 - August 2024 

• Know and develop competencies in regulatory processes in Colombia and Latam. 
• Verify that all technical and legal documentation collected, which will be submitted to regulatory entities is in accordance with the current regulations of each country. 
• Review the compliance of packaging materials and categorization of the Dossier Único project. Use of office tools such as PowerBI and Excel for document analysis. 

Student Assistant Universidad Nacional de Colombia, June 2023 - July 2023 

• Support in the process of generating labels for chemical reagents through the review of safety data sheets. 

Ticketing Operator Cinemark, November 2017 - September 2018 

• Customer service and resolution of doubts and problems. 
• Accurate recording of sales and cash handling. 
• Daily cash drawers and cash balances.

Química farmacéutica - Universidad Nacional de Colombia