Drive the global labeling strategy
Take a leadership role and partner with Global Regulatory Leads (GRLs) and other functional area partners
Lead target labeling development
Collaborate with functional areas to provide labeling input
Provide strategic labeling advice for local labeling in major markets
Analyze relevant competitor labeling
Lead Health Authority (HA) labeling strategy discussions
Lead the development, revision, review, agreement, and maintenance of target labeling
Lead cross-functional Labeling Working Group (LWG) and strategic labeling discussions
Represent global labeling in Global Regulatory teams and other cross-functional teams
Present at governance meetings
Ensure high quality and compliant labeling documents

Minimum of a Bachelor’s degree in a scientific discipline
Minimum of 8 years of professional work experience
Minimum of 6 years of direct regulatory labeling content experience
Direct experience with target labeling development or New Molecular Entity (NME) submissions preferred
Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc.) required
An understanding of pharmaceutical drug development required
Good understanding of worldwide regulatory guidelines and their application for guidance for labeling required
Experience leading project teams in a matrix environment required
Must have exceptional verbal and written communication skills
Must have strong organizational, negotiation, and partnering skills

Associate Director, Global Labeling Product Leader

Key skills