DANIELA OCAMPO CASAS

• Working within a TGA and PIC/S regulated pharmaceutical Australian manufacturing environment, supporting the production of pharmaceutical and nutritional products while strengthening practical knowledge of Australian GMP requirements, quality systems and regulatory expectations.
• Ensured compliance with Australian GMP requirements through meticulous maintenance of batch manufacturing documentation, line clearance activities, and in-process quality controls.
• Influenced GMP and Quality System enhancements by providing targeted regulatory recommendations that bolstered manufacturing compliance.
• Recommended and implemented GMP and Quality System improvements to advance company's Quality Management System.
• Apply previous Regulatory Affairs expertise to strengthen compliance and promote continuous improvement across manufacturing operations.

• Managed registrations and lifecycle variations for cosmetics, dietary supplements, and alcoholic beverages, securing timely regulatory approvals to support product launch timelines.
• Cultivated relationships with international manufacturers, regulatory authorities, and cross-functional stakeholders to ensure high-quality submissions and compliance, facilitating timely project delivery.
• Supported regulatory strategy by integrating technical, regulatory and commercial considerations across multiple product categories.

Key Project | Korean Medical Device Market Entry

• Led the end-to-end regulatory registration of 23 medical devices for a South Korean manufacturer, coordinating regulatory submissions, responding to technical deficiency letters and achieving 100% regulatory approval, enabling the commercialization in Colombia.
• Expanded the client's Colombian portfolio by securing 100% regulatory approval, enabling successful market entry.

• Supported regulatory activities across a portfolio of 1,800+ pharmaceutical, OTC and dermocosmetic products commercialized in more than 20 countries, managing product registrations, lifecycle activities and regulatory compliance across LATAM and the United States.
• Managed 20 lifecycle variations and two new product registrations monthly, ensuring timely submissions and regulatory compliance in multiple LATAM markets.
• Prepared and reviewed regulatory dossiers and technical documentation while coordinating change control activities with Quality, Manufacturing, Legal and Commercial teams to support product lifecycle management.
• Strengthened first-pass submission quality during INVIMA cyberattack, conducting rigorous technical and legal reviews to minimize regulatory deficiencies and avoid review delays during significant regulatory disruption.

Key Project | FDA Portfolio Transition

• Led the regulatory implementation following the acquisition of a U.S. consumer healthcare company, coordinating FDA notifications for ownership and manufacturing site changes across seven product families, including cosmetics, dietary supplements and consumer healthcare products.
• Successfully achieved 100% implementation of all required FDA regulatory updates, ensuring uninterrupted regulatory compliance and continued commercialization of the acquired portfolio.

• Promoted from Intern to Analyst based on outstanding performance.
• Coordinated regulatory submissions, lifecycle management, and compliance activities for pharmaceutical products across LATAM, enhancing regional regulatory project delivery and performance reporting.
• Managed a monthly regulatory plan targeting nine product registrations, achieving approximately 90% of planned submissions and reporting KPIs to Eurofarma's headquarters in Brazil.
• Prepared CTD dossiers and managed regulatory submissions while participating in change control activities to support effective product lifecycle management.
• Collaborated with marketing, quality, and manufacturing teams to ensure compliant artwork, labeling, and product claims prior to commercial launch, safeguarding regulatory standards.

Key Project | Regulatory Budget Optimization

• Recovered approximately 30% of historical regulatory expenditure, improving financial governance and supporting more efficient use of departmental resources.

• Supported CTD preparation, product registrations, and lifecycle activities, ensuring compliance through accurate regulatory documentation in SAP.
• Assisted with regulatory submissions while coordinating effectively between Regulatory Affairs and Quality teams to streamline processes.
• Developed and maintained regulatory databases to efficiently track product registrations and status updates, enhancing accessibility of information.