Overview In this role you will lead global regulatory labeling strategy and end-to-end labeling execution. You will partner with clinical, medical, market access, and commercial teams to craft timely labeling drafts and navigate health authority negotiations. You'll supervise labeling documents (TPL, CCDS, US/EU labeling) and ensure consistency with data and regulatory standards. You will drive cross-functional collaboration, stay current on labeling regulations, and support continuous process improvement to enable product success and lifecycle management.
Compensation / Benefits- competitive salaries
- excellent benefit package
Responsibilities- Develop labeling strategy with cross-functional teams and lead labeling meetings
- Lead creation, review, approval, and version control of labeling documents (TPL, CCDS, USPI/EU SmPC) per SOPs and regulatory requirements
- Provide expertise on labeling requirements and regulatory guidelines for development/maintenance of labeling
- Review competitor and class labeling to guide drafting and negotiation strategies with authorities
- Proofread and QC labeling deliverables ensuring data alignment and regulatory compliance
- Coordinate with cross-functional stakeholders to obtain input and resolve regulatory labeling issues
- Support labeling supplements and health authority interactions; disseminate approved labeling and supporting docs
- Maintain controlled records of labeling changes and communicate updates to stakeholders
- Build partnerships with other functions to align labeling with business goals
- Participate in continuous improvement of end-to-end labeling processes
- Monitor global regulatory environment and assess impact on labeling activities
- Support policy development and updates with internal stakeholders
Key requirements- Bachelor's degree in life sciences, computer science, or related discipline
- Minimum 8+ years in biotech/pharma labeling development/maintenance across two or more major geographies
- Knowledge of advertising/promotions regulations and FDA guidance with drug development labeling experience
- Experience leading cross-functional meetings and negotiations with internal stakeholders and regulators on labeling issues
- Ability to review regulatory labeling documents for accuracy and regulatory compliance
- Strong document formatting skills (MS Word, PDFs, validation tools)
- Professionalism, integrity, and diplomacy in all dealings
- cross-functional collaboration
- negotiation and influencing
- attention to detail
- regulatory labeling experience
- knowledge of labeling guidelines/regulations
- document management and version control
