Manager, Regulatory

📋 Description

• Execute regulatory strategies and submissions (IND/CTA/MAA) under regulatory requirements
• Lead compilation of Agency interaction documents (Meeting Requests/Packages)
• Lead labeling working group; USPI annotations and mockups
• Assist with regulatory activities across projects (clinical, non-clinical, CMC)
• Organizes regulatory files in RIM system to ensure compliance
• Mentor associates/contractors for regional requests

🎯 Requirements

• BA/BS in biological/physical sciences; advanced degrees preferred
• 5+ years regulatory affairs experience in biotech or pharma
• Strong understanding of drug development and regulatory requirements
• Strong written and oral communication and organizational skills
• Ability to interpret complex scientific info and guidelines
• Independent and collaborative work style under pressure
• Experience leading regulatory submissions and interactions
• Experience with document management and RIM systems; Veeva Vault preferred
• Proficient with MS Office for PM, tracking, writing, and presentations
• Strong problem-solving and attention to detail
• Professional image with stakeholders; autonomous time management
• Onsite at least 1x/week in New Haven HQ

🎁 Benefits

• Equal opportunity employer
• Hybrid work model with remote and New Haven HQ
• Competitive total rewards package
• Opportunity to contribute to regulatory programs in biotech