Drive the global labeling strategy, including understanding of competitors.
Take leadership role and partner with Global Regulatory Leads (GRLs) and other functional partners.
Lead target labeling development.
Collaborate to provide labeling input relevant to clinical study protocols.
Provide strategic labeling advice for local labeling in major markets.
Analyze relevant competitor labeling and develop labeling strategy and content.
Lead Health Authority (HA) labeling strategy discussions.
Lead the development and revision of labeling documents for assigned compounds.
Represent global labeling in cross-functional teams.

A minimum of a Bachelor’s degree in a scientific discipline is required.
Advanced degree (Master’s PhD, PharmD) in a scientific discipline is preferred.
A minimum of 8 years of professional work experience is required.
A minimum of 6 years of direct regulatory labeling content experience developing and writing labeling content for pharmaceutical products or equivalent is required.
Direct experience with target labeling development or New Molecular Entity (NME) submissions is preferred.
Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc.) is required.
An understanding of pharmaceutical drug development is required.
Experience leading project teams in a matrix environment is required.
Experience leading continuous improvement projects is required.
Experience working with document management systems is required.
Must have exceptional verbal and written communication skills.
The ability to manage compounds with a certain degree of complexity from a labeling perspective is preferred.

Associate Director, Global Labeling Product Leader

Key skills