Senior Director, Regulatory Affairs

📋 Description

• Lead global regulatory strategies across pipeline and marketed products.
• Serve as primary regulatory strategist on cross-functional teams.
• Provide regulatory intelligence, risk assessments, and executive briefings.
• Lead interactions with FDA, EMA, and other authorities (Type A/B/C meetings, Scientific Advice).
• Guide regulatory planning for endpoints, populations, statistical analysis, and labeling.
• Oversee submissions planning, timelines, and cross-functional teams.

🎯 Requirements

• Bachelor’s degree in life sciences, pharmacy, chemistry, or related field; advanced degree
• 12+ years regulatory affairs experience in pharma/biotech/medical devices.
• Proven success leading BLA, NDA, or MAA submissions.
• Deep knowledge of FDA 21 CFR, ICH guidelines; EMA and global frameworks.
• Experience leading Health Authority meetings and high-stakes interactions.
• Strong strategic thinking, communication, negotiation, and leadership skills.

🎁 Benefits

• Base salary range: $259,000–$317,000, with final compensation based on experience.
• Annual bonus target eligibility.
• Equity incentives and 401(k) plan with employer match.
• Medical, dental, vision coverage; life and disability benefits.
• Paid parental leave (12 weeks) and organ/bone marrow leave (12 weeks).
• Flexible time off and annual winter holiday shutdown.