Strategic Regulatory Affairs Professional with diverse and progressive experience leading growing or established companies in the pharmaceutical, biotech and medical device industry providing global strategic regulatory direction for both new and existing products, as a primary contact facilitating preparation of international regulatory documents. Advances the development of knowledge, products, people, collaboration, contributing to teamwork and company priorities.

Highlights:

• Product Registration
• CMC
• International Submissions
• Global regulatory
• BLA, INDs, Orphan Drugs
• Project Management
• Bilingual
• International regulations