A minimum of 12 years required of industry experience and extensive experience (at least 4-6 years) in global labeling, alternatively extensive experience in related areas of the Pharmaceutical Industry or Health Authorities.
Experience negotiating with internal and external stakeholders on complex regulatory issues of importance to BioMarin.
Seasoned regulatory professional with experience in submissions for products in development and commercial products.
Thorough understanding of regulatory labeling requirements and strategic labeling planning.
Outstanding interpersonal and communication (written and verbal) skills.
Attention to detail and highly organized.
Prior experience leading cross functional teams.
History of solving regulatory labeling related problems while exhibiting superior judgment and a balanced, realistic understanding of issues.
Fluency in English as business language, additional languages advantageous.
Minimum requirements Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred.