Regulatory Affairs Global Labelling Manager

Responsibilities:

• Serve as the labeling lead for all labeling related topics.
• Maintain regulatory compliant, competitive and up to date global labeling documents (Core data sheet (CDS), Basic Patient leaflet (BPL), Basic Succinct Statement (BSS) for assigned products.
• Present to GLC on CDS changes.
• Organize and lead the ELTF to discuss labeling strategy and reach consensus on labeling course of action and labeling text as appropriate.
• Represent GL as a core member of RA Sub-teams, and Safety Management Teams (SMTs) for assigned projects/products.
• Research and understand the labeling topic including reviewing labels across different markets, competitor labels, study information, labeling regulations, etc.
• Contribute to the creation of high quality documents supporting changes to the CDS and responses to labeling-related Health Authority queries
• Interact with COs to ensure timely implementation of global labeling changes in local product information, and ensure international consistency and compliance with the CDS.
• Contribute to RA activities regarding safety risk communications/portfolio stewardship activities having labeling impact for their assigned projects/products.
• Contribute to/lead presentations on labeling related topics for the assigned products at relevant board/forum/committee (e.g., MSRB, PSB).
• Prepare and/or review PSUR RA input for assigned products.
• Review and release International Package Leaflets for assigned products.
• Contribute to global labeling management and continuous improvement initiatives.
• Review and comment on emerging internal and external guidelines and regulations on regulatory, safety, and legal topics.
• Represent GL during audits and inspections.

Experience:

• Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, PhD, PharmD) preferred.
• Extensive experience (at least 4-6 years) in global labeling, alternatively extensive experience in related areas of the pharmaceutical industry or Health Authorities.
• Strong interpersonal, project management, communication, negotiation and problem solving skills.
• Ability to lead cross-functional teams in a matrix environment
• Good understanding of drug safety information