Proven leader and organized professional with extensive experience in regulatory affairs and product compliance mostly in the food and food supplement industry. Excelled in developing strategic plans, achieving cost savings and reducing negative impact of upcoming regulations. Skilled in collaboration and negotiation, with a strong focus on results.
-Work closely with departments such as R&D, QA, Marketing to successfully develop and commercialize products which comply with local regulations as well as international regulations.
-Obtain Sanitary Registrations for products in the following categories: food, food supplements, cosmetics and natural health products.
-Collaborate with department heads to develop strategic plans for the country to avoid or minimize impact of upcoming regulations.
-Participate in Regulatory Committees in the country to develop local regulations (most of the time based on US regulations) for products such as Food Supplement Regulation.
-Attend Ministry of Health audits for registered products.
-Attend consumer questions on products as well as giving training to company ambassadors.
-Founder of the Regulatory Affairs Academy for the Central and South America region, which is a space for areas to share expertise and knowledge to boost day to day work.
-Carried out the documentary analysis and obtaining Health Notifications, GMP Registration Certificates for foods and cosmetics for mass consumption. As well as make their respective modifications and renewals.
-Participated in the documentary audit process and procedures before Ministry of Health for the sale of the following cosmetic brands: Bioexpert, EGO, Fortident and Savital to Unilever
-Implemented an improvement process in the document management of dossiers.
- Relaunched the sensory evaluation program with internal consumers with training for all company personnel.
- Carried out online product sensory evaluations and future launches with internal experts whom I trained. The internal experts came mainly from the R&D and marketing areas.
Participated in certain regulatory review committees such as the INEN food labeling regulations.
As a Master of Food Science student, I worked as an intern in the Quality Assurance Department. Part of my achievements were to develop a traceability process for raw materials and packaging materials developing forms to trace documentation and processes.
-Evaluated the efficiency of the sachet packaging line, creating forms for machine stoppages, stoppage times and production per machine. With this, it was possible to optimize the time of the operators and reduce expenses by around $30,000 due to a reduction in overtime and night shifts. I trained the operators and the leader of each line to use the reports and together we improved the document to obtain more assertive results.
- Prepared reports for the production lines of hot sauces and cold sauces based on flow charts to optimize resources and improve line flows. I trained the operators and leaders of each line to use the reports.
-Formulated locally produced garlic sauce for the Papa Johns pizza chain due to import restrictions. I worked together with the client for the development and approval of the formula and production process and product registration with ARCSA.
- I carried out the creation of stability protocols for internal control of the company.
- I supported the survey of the area with protocols, documents and registration processes.
Results oriented
Organized
Able to collaborate with teams of different areas
Communicative
Able to negotiate
Leader