Associate Director, Global Regulatory Affairs Labeling
United StatesFull-TimeManager
Salary not disclosed
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Job Details
- Experience
- 8+ years of experience in biotech or pharmaceutical industry, including 4+ years in global regulatory labeling roles
- Required Skills
- Cross-functional Team Leadership
Requirements
- Bachelor’s degree in life sciences required; advanced degree preferred
- 8+ years of experience in biotech or pharmaceutical industry
- 4+ years in global regulatory labeling roles
- Strong understanding of global drug development regulations and labeling requirements across major health authorities
- Proven experience developing and managing global labeling content across multiple markets
- Strong cross-functional leadership skills with ability to influence in a matrix environment
- Excellent communication, stakeholder management, and negotiation abilities
- Strong analytical mindset with attention to detail and ability to manage multiple priorities
- Experience working in fast-paced, evolving environments with ambiguity and changing priorities
Responsibilities
- Define and drive global labeling strategies, including target label development and alignment with clinical and regulatory program goals
- Develop and maintain core labeling documents such as CCDS, prescribing information, SmPCs, patient leaflets, and instructions for use
- Lead cross-functional labeling activities and facilitate alignment across Regulatory, Clinical, Safety, Medical Affairs, Legal, Quality, and Commercial teams
- Manage labeling changes across product lifecycle, ensuring timely implementation and global consistency across markets
- Coordinate Label Working Group and Label Review Committee activities, driving consensus on complex labeling issues
- Prepare regulatory documentation supporting submissions, health authority interactions, and approval milestones
- Oversee labeling compliance, quality control, document management, translation verification, and artwork review
- Contribute to process improvements, governance frameworks, and labeling system enhancements
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