Senior Manager, Regulatory Affairs

📋 Description

• Lead regulatory submissions (INDs/CTAs/NDAs/BLAs/PIPs/PSPs) with teams.
• Collect data and author docs; coordinate submission content.
• Communicate timelines and ensure on-time submissions.
• Interface with regulatory publishing for FDA and ex-US submissions.
• Archive and maintain submissions in regulatory information management system.
• Implement standardized templates; provide formatting guidance.
• Understand US/international requirements; mentor teams and collaborate with CROs.
• Support global regulatory leads to meet trial deliverables.

🎯 Requirements

• BS/MS/PhD in regulatory affairs or related science.
• RAC certification preferred.
• 5+ years regulatory exp in drug development.
• Experience with FDA and EMA interactions.
• Strong PM skills; ability to collaborate cross-functionally.
• Strong communications; tailor messages to stakeholders.
• Experience with Veeva RIM, eCTD, MS Office SharePoint/Teams.
• Demonstrates CORE values: Caring, Original, Resilient, Egoless.
• Travel up to 10% (in-person All Hands twice yearly).

🎁 Benefits

• Culture rooted in CORE values: Caring, Original, Resilient, Egoless.
• Fast-paced environment; wear multiple hats.
• Competitive comp and benefits: salary, bonus, equity, health, retirement.
• Generous PTO, two company shutdowns, paid sick leave.
• Professional development resources.
• All-team in-person meetings to build relationships.