SANDRA YAZMIN ARIZA

• Provided strong leadership to enhance team productivity and maintain a good work environment.
• Shaped regulatory environment through TA, scientific societies and government entities relationship.
• Carried out the planning process of regulatory strategies for the achievement and maintenance of the registrations in the North Region (Colombia, Central America and Ecuador)
• Managed large-scale projects and introduced new systems, tools, and processes to achieve to improve productivity.
• Conducted performance evaluations, compensations and hiring to maintain appropriate staffing requirements.

• Responsible for the regulatory and QA operations in the North region, with 5 direct reports. Addressing and support to local managers.
• Designed and implemented regulatory strategies to protect, maintain or expand the portfolio.
• Defended the registration categories, through an articulated engagement, with government, industries and health entities.
• Conducted risk assessments to identify and mitigate potential quality issues.
• Assessed product quality by monitoring quality assurance metrics, reports and dashboards.
• Ensured the QA & RA compliance in local and abroad audits from authorities and corporate area.
• Provided technical support to the general manager and commercial and marketing areas in all matters required.

• Head of ANI Colombia Regulatory Affairs . Responsible for the registration processes before authorities to obtain new sanitary registrations, modifications and Re-registration of drugs, food and medical devices in Colombia.
• Reviewed and approved promotional material ensuring compliance with the internal polices and local regulations.
• Defended Abbott positions in local codex committee and trade associations.
• Co- responsible for the pharmacovigilance programme.
• Leaded the development of local FSMP regulation. Maintaining the registrations of the products as drugs, according business needs.

• Ensured success in registration processes of pharmaceuticals, dietary supplements and cosmetics in Colombia and Andean Region.
• Co-Responsible for the pharmacovigilance programme along with the medical direction.
• Reviewed Drug’s information (Trials, Bioavailability and Bioequivalence Studies) for Pharmacological assessment requested to the Revision Committee - INVIMA (Local MoH agency).
• Responsible for errands at the National Narcotics Fund. Contacting and monitoring international suppliers for new products’ purchase.
• Monitored new products’ local development.
• Supervised artworks (creation and change control) for new products and registered products.
• Controlled and monitored of application processes of branding. Review of promotional material.

• Responsible for the Quality Control Laboratory, coordinating and monitoring the analysis of raw materials, packaging materials, in-process and finished products.
• Followed quality standards and procedures to minimize errors and maximize customer satisfaction.
• Updated quality control standards, methods, and procedures to meet compliance requirements.
• Managed and updated of the stabilities and validation programs.
• Reviewed of technical packages for registration requests and technical support to RA requirements.

• Temporary teacher of Pharmacology II. Responsible for topics related to chemotherapy (Antibiotics, Antimycotics, Antineoplastics)
• Implemented of workshops where the student analyses and integrates the knowledge acquired in a practical and critical way.
• Answered questions from students regarding instruction material
• Promoted positive learning environment in classrooms for students

Head of the group of laboratory analysts.

• Coordinated and supervised activities in the area.
• Managed of the Stability Programme long-and short-term, review of validations of analytical techniques.
• Standardized and validated different analytical methods HPLC, SOP processing, analyzed finish product and raw materials.
• Managed working standards and reference standards program.
• GMP Internal Auditor

• Analyzed raw materials and finished product.
• Communicated with production team members about quality issues.
• Developed of standard operating procedures.
• Standardized and validated analytical methods, analyzed finished products and raw materials.
• Head of the Stability Programme in short/long term.