Plena Global Holdings

- Support the business area for product development and regulatory strategy in countries of interest.
- Maintains and directs the business's daily operations, including coordinating with production, support, and administrative areas.
- Present, follow-up, and answer of requirements in regulatory submissions from local authorities as ICA, Ministry of Justice, Ministry of Health, INVIMA, and support in other LATAM countries.
- Promote adequate and strategic relationships with government entities and industry associations, including participating in events, meetings, forums, to keep updates to the company in regulations and guidelines in health and agro laws. 
- Represent the company as an authorized person to the authorities and technical representative to the narcotics control entity.
- Support inter-areas design, development, and implementation of Quality Management Systems (GMP, ISO, GACP) at the operation site.

COO & Technical Director

GMP Solutions SAS

-To Lead and development projects for clients from  health sector and pharmaceutical companies: pharmaceutical regulatory affairs and quality management systems  (GMP, GCP, BPE, Health licenses INVIMA - ICA, and patents ). Also, Integrated Management Systems (ISO 9001,  ISO 13485, ISO 15378) and Import procedures orphan drugs.

Founder

Sanofi Genzyme

-	Management of new molecules Marketing Authorization and other submissions as renewals, modifications, and orphan drugs process, to local regulatory entities.
-	Attend guidelines and regulations review, tender requirements, and others related to company products.
-	Back-up of integrated Pharmacovigilance / Technovigilance program for all Sanofi group.
-	Support audit by INVIMA of CCAA certificate (for medical devices).
-	Design, evaluate and submit INVIMA secondary packaging material (box, blister, insert) of the company's products.
-	Manage CAF and CAPAs of the regulatory affairs process Colombia.
-	Support in functions of AQO and local document management.
-	Participate in ANDI, AFIDRO, PUNTO AZUL meetings related to regulation and quality.

Manager Regulatory Affairs & AQO

Evolucia 

-	Create and implement of Quality Management System: Good Compounding Practices  and CCAA for Ophthalmic medicines and Medical Devices.
-	Technical support to ophthalmic products: R&D, regulatory affairs.
-	Quality control for process and products.
-	Sanitary registers for dietary supplements, Medical Devices and medicines. 
-	Attend INVIMA audits and client inspections.

Regulatory Affairs and Technical Director

CAYRE-Riesgo de Fractura

-	Implementation of Quality Management System in research of medical products: 
	Good Clinical Practices.
-	Design and implementation of Technovigilance and pharmacovigilance program.
Participation in research group phase III studies and Phase IV for rheumatology biologics.
Preparation and submit research information for Technical Committee in INVIMA.

Clinical Trial Pharmacist

INVIMA, National Institute of Food and Drug Monitoring in Colombia

-	Audits in Good Manufacturing Practices to National and International companies.
-	Conducting surveillance and control pharmaceutical establishments: medicines, cosmetics, homeopathic, herbal and medicinal gases.
-	Participation in structuring and evaluation of health regulations.
-	Participation in the Pan American Network for Drug Regulatory Harmonization- Network PARF.
-	User support related to health issues.

Auditor / Professional of Drug and Biological Products Department

Boehringer Ingelheim

-	Physic-chemist analyze for final product (medicines and herbal products) and their stability studies.
-Help in meeting annual goals pending in the area of quality.

Quality Control Analyst

Universidad Nacional de Colombia

-	Structuring the Quality System at the ICTA.
-	Implementation of Good Manufacturing Practices for food.
-       Academic review of Colombian food normative.

Quality  Intern

At Plena Global Holdings, leadership and a strategic approach to regulatory affairs underpin my role as COO and Technical Director. My competencies are rooted in directing business operations and developing regulatory strategies, ensuring product compliance across diverse markets. Our team adeptly navigates health and agro laws, contributing to the company’s adherence to local and international standards.

With a prime focus on quality management systems, I spearhead initiatives that foster strategic relationships with government entities and industry associations. This role involves persistent engagement with regulatory submissions and the promotion of standards that guide our product development. By representing Plena Global Holdings in key industry forums, we maintain a pulse on evolving regulations, positioning us at the forefront of compliant and innovative operations.

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