Regulatory Affair Director - Global Regulatory Leader (Rare Disease)

Responsibilities

• Develop comprehensive global regulatory strategies for product development
• Lead global regulatory team efforts in registration strategies and development plans
• Guide the creation of core data sheets to align with regulatory requirements
• Oversee planning and implementation of global regulatory filings
• Monitor and assess impacts of global regulatory changes on products

Qualifications

• Doctorate degree and 4 years of related experience; OR Master's degree and 8 years; OR Bachelor's degree and 10 years of related experience
• Minimum 4 years of managerial or leadership experience
• Strong communication skills in both oral and written formats
• Able to comprehend and relay scientific/clinical information effectively
• Experience in anticipating strategic issues and mitigating risks

Benefits

• Comprehensive employee benefits including health insurance and retirement plans
• Stock-based long-term incentives to share in company growth
• Award-winning time-off plans for work-life balance
• Flexible work models when applicable to provide better work-life integration