Regulatory Affairs Consultant – Global Labeling Lead

🌍 Remote, USA 💹 Full-time 🕐 Posted Recently

Job Description

Drive the labeling development and strategy, in-line with overall global strategy.
Provide labeling expertise for Company Core Data Sheet (CCDS) and local labeling (USPI, SmPC and other).
Evaluate and communicate strategies and anticipate risks associated with labeling content and timelines.
Lead or contribute to cross-functional teams to align the development and maintenance of global labeling for assigned compounds.
Partner with Global Regulatory Affairs to ensure all labeling is aligned with product global strategy.
Support global Health Authority interaction strategy regarding all aspects of labeling.
Collaborate with global colleagues and partners as needed.
Develop clear communications for senior management and labeling stakeholders.

BSc or advanced scientific degree (MSc, PhD or PharmD) preferred.
6-8 years of relevant pharmaceutical Labeling/Regulatory experience.
Thorough understanding of scientific principles and regulatory systems, relevant to drug development.
Experience writing CCDS and local labeling documents for new products.
Solid understanding and practical knowledge of labeling regulatory requirements, regulations and guidance required.
Ability to prioritize and manage multiple high to medium complex projects simultaneously.
Strong attention to detail.
Preference for experience with IT systems; knowledge of Regulatory Information Management System (RIMS) and electronic document management system (EDMS); proficiency in MS Office suite.