Director, Regulatory Affairs, Labeling

This Director of Regulatory Affairs, Labeling position leads the generation and revision of core labeling documents for various products. The role involves collaboration with experts and GRLs, ensuring compliance with regulatory guidelines and navigating interactions with Health Authorities. Responsibilities include managing labeling development, preparing updated documents, and advocating for labeling best practices within the company.

Requirements

• High level of applied knowledge of applicable FDA laws, regulations, guidance, and industry standards.
• In-depth understanding of clinical trial design and interpretation.
• Strong interpersonal skills and communication skills.
• Ability to communicate complex issues clearly and concisely.
• Proven track record in regulatory labeling and related strategies.
• Significant experience with NDA/BLA labeling and negotiations.
• Experience working with a broad range of regulatory labeling documentation.

Benefits

• Competitive salary
• Health insurance
• Paid time off
• Retirement plan
• Diversity and inclusion programs