Mary Wilhelm

About Mary Wilhelm

Regulatory affairs professional with extensive experience in clinical and post approval drug development activities. Includes EU MAA and US BLA approvals and successful Advisory Committee meeting preparations. Strengths include developing regulatory intelligence and strategy, preparing regulatory submissions, and interacting with domestic and international regulatory agencies. Experienced in preparing teams for regulatory agency meetings, managing interface with agencies and certifying bodies for site inspections, organizing regulatory agency meetings and preparing submissions. Proven expertise in developing, applying, and maintaining a compliant quality system per FDA and ISO requirements. Demonstrated communications, interpersonal, and leadership skills. Mentors and develops other regulatory professionals.

Experience

1. Head, Regulatory Policy & Intelligence

   Ascendis Pharma

   Jan 2024 — Present · San Diego, CA, US

Education

• Purdue University

  Bachelor of Science (B.S.), Textile Science

• University of Southern California

  Doctor of Science, Regulatory Sciences

  2016 — 2021

• Purdue University

  Master of Science (M.S.), Chemistry

• San Diego State University

  Master of Science (M.S.), Regulatory Affairs

• Purdue University

  Bachelor of Science (B.S.), Chemistry

Skills

• U.s. Food and Drug Administration (Fda)
• Glp
• Oncology
• Life Sciences
• Drug Development
• Biopharmaceuticals
• Regulatory Affairs
• Clinical Research
• Biotechnology
• Drug Discovery
• Partner Programs
• Biologics
• Gmp
• Ind
• Clinical Development
• Nda
• Regulatory Submissions
• Quality System
• Quality Assurance
• Good Laboratory Practice (Glp)
• Pharmaceutical Industry
• Sop
• Fda