Director, Regulatory Labeling Strategy (Remote-Eligible)

Responsibilities

• Ensure compliance with labeling governance and business processes
• Lead label working groups and represent labeling at global regulatory teams
• Develop and maintain global product labeling, including CCDS and regional documentation
• Advise stakeholders on regulatory labeling requirements and oversee health authority interactions
• Conduct research on labeling regulations and strategies to impact outcomes
• Lead strategic development and lifecycle management of labeling for therapeutic areas
• Collaborate with teams to prioritize and execute projects related to regulatory labeling

Qualifications

• Bachelor's degree required
• 10 years of experience in regulatory affairs or global labeling
• Strong knowledge of global regulatory authorities and their labeling requirements
• Experience leading label development and negotiations for marketing applications
• Advanced skills in project management and regulatory compliance
• Familiarity with emerging technologies relevant to regulatory labeling

Benefits

• Inclusive market-leading benefits package
• Generous paid time off including a week-long company shutdown
• Educational assistance such as student loan repayment
• Commuting subsidy and matching charitable donations
• 401(k) plan with employer contributions
• Flexible work options including remote, hybrid, or on-site arrangements