

Based in US can be remote, but some travel to in the US and other locations as needed to support business needs.
SUMMARY
The Director of Regulatory Global Labeling (REG-GL) is a strategic leadership role working with a team to develop and managelabeling for products worldwide. Responsibilities may include developing labeling content and strategies for Target Product Labeling, Company Core Data Sheets, Prescribing Information, Patient Labeling, and Instructions for Use. The incumbent will beresponsible for regulatory compliance, competitive, and up-to-date labeling.The Director of REG-GL will lead cross functional Product Labeling Teams as a Global Labeling Leador supervise staff in this role, directing team members on labeling content, requirements, and strategies for good labeling outcomes and success. This role would also be responsible for strategic regulatory labeling health authority interactions and negotiations for labeling projects assigned. End to end labeling process oversight is expected for products assigned to ensure proper handoff and compliance. Oversees and mentors labeling professionals to achieve regulatory objectives.
This position will be responsible for:
RESPONSIBILITIES
EXPERIENCE
Required Skills:
A minimum of 7 years required of industry experience and extensive experience (at least 4 years) in labeling; alternatively extensive experience in related areas of the Pharmaceutical Industry or Health Authorities.
•Experienced leader with management and direct reports.
•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.
•Excellent writer or labeling content with attention to detail.
•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.
Desired Skills:
•Expertise in global labeling and managing project teams including international teams (not in the same time-zone).
•Biologics and rare disease experience is desirable.
•US labeling expertise required,with additional International and Core Labeling experience desired.
EDUCATION
Minimum requirements Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred.