Daniel Preval Ramirez

Client: Takeda Pharmaceuticals Therapeutic Area: Oncology. • Assisted cross-functional teams in planning, executing, and timely submission of development and lifecycle regulatory projects, including INDs, MAAs, Renewals, and Post-Approval Variations (Clinical and CMC). • Facilitated project meetings, communicated project status, and solved issues promptly. • Supported stakeholders in preparing project plans and visuals, tracked progress, identified potential risks, and developed mitigation strategies.

• Regulatory Affairs Specialist. Project Manager for in-licensing products in the APAC region. (KR, PH, MY, SG, TH, TW, HK, and VN). • Compilation, review, and publishing of product dossiers following local requirements. (eCTD, NeeS, PDF). Regulatory Activities: MAA, DMF, pre- and post-approval variations, and cumulative dossiers. Compilation Software: Lorenz Docubridge.

• Handled 20+ customer interactions per day, giving detailed, personalized, friendly & polite service to ensure customer satisfaction. • Increased gross and net profit records across 2016-2018, achieving double-digit growth results. • Trained new employees in how to use our database, entering customer data and organizing customer interaction. • Received a 98% customer satisfaction rating, 17% higher than the company mean. • Led crisis management team and provided quick turnaround solutions.

• Reviewed Administrative and CMC information of 25+ regulatory submissions including CTAs, MAAs, pre-approval & post-approval changes, and Annual Product Quality Reviews. • Provided timely written reports of quality/regulatory compliance status. • Performed 15+ Quality Audits/GMP inspections at manufacturers of medicinal products for human use. • Provided timely written reports of quality/regulatory compliance status. • Supported the implementation of new or revised legislation/guidelines.

Researched on the transient and stable expression of recombinant proteins in transgenic tobacco leaves. Investigated on suppressors of the post-transcriptional gene silencing. Increased the expression of the monoclonal antibody anti Hepatitis B Surface Antigen (Anti-HBsAg) in plants of Nicotiana tabacum L., by using the viral suppresor P19 del Tombosvirus and the Matrix Attachement Region (MART2).

main skills: molecular & cellular Biology, microbiology, immunology, virology, genetics, genetic engineering, immunochemical techniques, characterization of materials, statistics.