Daniel Preval Ramirez

Client: Takeda Pharmaceuticals.

Therapeutic Area: Oncology.

• Led cross-functional project meetings to ensure alignment, resolve issues, and drive execution.
• Coordinated 15+ global regulatory submissions, including MAAs, renewals, and CMC/clinical variations across the US, EMEA, LATAM, and APAC.
• Organized project kick-off meetings, maintained trackers, recorded meeting minutes, and delivered regular status reports to stakeholders.

An ALVOGEN Company.

• Executed regional submission strategies for in-licensed products across APAC, meeting local regulatory expectations.
• Effective cross-functional communication with internal and external stakeholders on regulatory issues.
• Contributed to eCTD/NeeS dossier compilation and quality checks, with a focus on technical sections.

• Used consultative sales techniques to understand customer needs and recommend relevant products and services.
• Followed up with existing customers to provide additional support and address concerns.
• Increased sales with execution of full sales cycle processing from initial lead processing through conversion and closing.

• Used consultative sales techniques to understand customer needs and recommend relevant products and services.
• Built relationships with customers and community to establish long-term business growth.
• Exceeded sales quotas and increased profitability through effective sales strategy and business planning.

National Regulatory Authority of Cuba.

• Assessed CMC dossiers for biotech products during clinical, registration, and post-registration phases.
• Conducted 15+ GMP inspections and issued compliance reports for local manufacturers.
• Contributed to the development of local regulatory guidelines for biotech products

Centre of Genetic Engineering and Biotechnology

• Researched and developed molecular strategies to increase the transient and stable expression of recombinant proteins and monoclonal antibodies in plants.
• Investigated viral plant proteins, suppressors of the post-transcriptional gene silencing.
• Increased the expression of the monoclonal antibody anti-hepatitis B Surface Antigen (Anti-HBsAg) in leaves of Nicotiana tabacum L., by using a viral suppressor protein of the post-transcriptional gene silencing and a Matrix Attachment Region.