Dohan Weeraratne

About Dohan Weeraratne

Dynamic and strategic regulatory affairs leader with proven expertise driving global regulatory strategy, submissions, and compliance across multiple regions, including the U.S, EU, and emerging markets. Adept at leading cross-functional teams to develop and execute regulatory pathways that accelerate product development, approval, and lifecycle management. Skilled in interpreting complex regulatory requirements, mitigating risks, and ensuring alignment between global regulatory expectations and business objectives. Recognized for strong communication, influential leadership, and the ability to build high-impact partnerships with health authorities, internal stakeholders, and external collaborators.

Experience

1. Senior Manager Regulatory Affairs - Global Regulatory Lead

   Amgen

   Mar 2025 — Present · Thousand Oaks, CA, US

   Develop global regulatory strategic plan and provide regulatory input into product\'s global regulatory strategyDevelop registration strategies and plans to achieve regulatory approval and product labeling

Education

• University of Southern California

  Master's degree, Regulatory Science

• University of Southern California

  Master's Degree, Regulatory Science

• UC Santa Barbara

  BS, Biochemistry

Skills

• Microsoft Office
• Project Management
• Clinical and Pre-Clinical Program Support
• CRO Oversight
• External Research Collaboration and Contract Negotiation
• Immunogenicity (Ada) Assay Development Using Biacore, Msd. Elisa, Immunocap
• Glp, Gcp, and 21 Cfr Part 11 (Systems & Electronic Data Validation)
• Staff Training and Mentoring
• Communication and Presentation
• Problem Solving
• Risk Assessment & Risk Management
• Pharmacokinetic (Pk) Assay Development Using Msd, Gyro Lab, Elisa, Octet
• Presentation Skills
• Biotechnology
• Pharmaceutical Industry
• Molecular Biology
• Life Sciences
• Biopharmaceuticals