María Isabel Aparicio
Panama City,
Summary
Dynamic Regulatory Affairs Coordinator with a proven track record at PHARMAVITAL S.A, enhancing compliance and fostering collaborative relationships. Expert in regulatory submissions and adept at cross-functional team leadership, I've successfully managed product launches and regulatory strategies, ensuring adherence to evolving regulations. My adaptability and commitment to excellence have driven significant improvements in process efficiency and stakeholder communication.
Overview
7
7
years of professional experience
Work History
Regulatory Affairs Coordinator
PHARMAVITAL S.A
Santa Maria Business District Office Plex 71
06.2021 - Current
- Enhanced regulatory compliance by developing and implementing effective policies and procedures.
- Developed strong collaborative relationships with partners and providers, fostering open communication channels to enhance effective problem-solving.
- Managed the preparation, review, and submission of high-quality regulatory filings.
- Evaluated internal processes to identify areas for improvement within the context of applicable regulations.
- Facilitated communication between departments to ensure a seamless flow of information related to regulatory affairs.
- Championed regular reviews of existing products to confirm ongoing compliance with changing regulations.
- Coordinated responses to inquiries from regulatory authorities, demonstrating professionalism and expertise in addressing concerns.
- Supported successful product launches by coordinating effective regulatory strategies.
- Maintained up-to-date knowledge of relevant regulations and guidelines, ensuring company adherence to requirements.
- Advised project teams on potential labeling updates based on evolving market demands or changes in regulation.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Managed all regulatory needs for products such as Pharmaceutical Products, Medical Devices and Cosmetics.
Regulatory Affairs Associate
Mediequipos S.A (Hogar Y Salud)
Via Israel,71th Street
11.2018 - 06.2021
- Prepared and maintained document inventory for core dossier preparation.
- Managed post-approval changes, ensuring all necessary documentation was submitted accurately and on time.
- Enhanced regulatory compliance by meticulously reviewing and editing submission documents.
Retail Pharmacy Assistant
Solumedic S.A
Punta Pacifica
01.2018 - 07.2018
- Enhanced pharmacy efficiency by accurately stocking shelves and maintaining inventory control.
- Provided superior service by actively engaging with customers, listening attentively to their needs, and offering helpful advice.
- Maintained a clean and organized workspace, promoting a positive environment for customers and staff alike.
- Assisted store management with general retail tasks such as merchandising displays and cashier duties when needed.
Education
Master Registro De Medicamentos YFarmacovigilancia -
IMF SMART EDUCATION
01-2026
Bachelor in Pharmacy -
Universidad De Panama
Panama05-2018
Skills
- Regulatory submissions
- Product labeling
- Medical device regulations
- Document management
- Stakeholder communication
- Cross-functional team leadership
- Decision-making
- Adaptability and flexibility
Languages
Spanish
Native language
English
Proficient
C2
Additional Information
Personal Reference: Jorge Cedeno 63793889 Regulatory Affairs Specialist
Sandra Famiglietti 66756669 Regulatory Affairs Specialist
Yulissa Mendoza 63284926 Regulatory Affairs Specialist
Timeline
Regulatory Affairs Coordinator
PHARMAVITAL S.A
06.2021 - Current
Regulatory Affairs Associate
Mediequipos S.A (Hogar Y Salud)
11.2018 - 06.2021
Retail Pharmacy Assistant
Solumedic S.A
01.2018 - 07.2018
Master Registro De Medicamentos YFarmacovigilancia -
IMF SMART EDUCATION
Bachelor in Pharmacy -
Universidad De Panama