Fatou Lo

Currently working as a Regulatory Affairs Consultant at Nestlé Health Science, focusing on drug regulatory affairs management, including MAA and product lifecycle management. Responsible for ensuring compliance and managing projects effectively.

Contracted as a Regulatory Affairs Consultant, successfully established a RIMS project, focusing on data entries, migration, and document quality review for regulatory submissions across multiple regions.

Redesigned regulatory affairs processes to meet compliance requirements and managed submissions for influenza vaccine products. Improved project management activities and strengthened relationships with health authorities.

Coordinated internal study protocol approval workflows and managed regulatory changes for multiple pharmaceutical companies, ensuring compliance with local regulations.

Monitored global variation projects and provided regulatory support for high-priority submissions, ensuring compliance and timely communication with regulatory authorities.

Served as a single point of contact for clinical trial notifications, providing regulatory advice and ensuring compliance with Swiss regulations.

Contracted to support regulatory affairs at Amgen, focusing on compliance and documentation for clinical trials and regulatory submissions.

Coordinated the approval process for generic drugs, maintained submissions, and collaborated with marketing and sales for new drug introductions.

Conducted method validation for diagnostic test kits and routine analysis for genetic metabolic diseases.

Developed and implemented a new product segment in quality assurance for clinical toxicology, ensuring compliance with ISO standards.

Achieved a certificate in Regulatory Affairs Project Management, focusing on project management principles within the regulatory context.

Completed a certificate program on CMCDocumentation & Post-Approval Changes/Variations, enhancing knowledge in regulatory documentation.

Completed a course on Investigator Initiated Studies, focusing on the regulatory aspects of investigator-initiated clinical trials.

Participated in an intensive course on Regulatory Affairs in Asia, covering the regulatory framework and guidelines in Asian countries.

Completed a specialized course in EU Regulatory Affairs, focusing on regulatory guidelines, application procedures, and variations regulations.

Completed a professional education program to become a Medical Laboratory Assistant Technician, gaining essential skills in laboratory practices and procedures.