Mary Wilhelm
Head, Regulatory Policy & Intelligence @Ascendis Pharma
Signup · Get unlimited contacts
WORK HISTORY
Head, Regulatory Policy & Intelligence @Ascendis Pharma
San Diego, CA, US
EDUCATION
Purdue University
Bachelor of Science (B.S.), Textile Science
University of Southern California
Doctor of Science, Regulatory Sciences
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
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.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.