Exec Director/VP Regulatory Affairs

📋 Description

• Represent regulatory on program and study teams and in disease area strategy and planning meetings
• Develop regulatory strategies to ensure development plans are comprehensive and comply with
• Lead or support preparation and review of regulatory documents (e.g., IND, CTA/IMPD, DSUR
• Act as Regulatory Affairs representative in business development and due diligence activities
• Review relevant clinical documents for scientific content and regulatory compliance
• Act as primary liaison with the FDA and OUS health authorities to facilitate timely review and

🎯 Requirements

• Undergraduate degree required; advanced degree preferred
• 10+ years of relevant experience in pharma or biotech regulatory affairs required, including deep
• Proven knowledge and experience in US and EU regulatory affairs required (e.g., IND, CTA, CTN, NDA)
• Experience with NDA submission and product approval preferred
• Experience with expedited programs for serious conditions such as FastTrack, Breakthrough Therapy
• Proven knowledge of FDA and ICH guidelines

🎁 Benefits

• Paid Time Off
• Holiday
• Sick Leave
• Medical, Dental and Vision Plans
• Short- and Long-Term Disability
• Basic and Voluntary Life/AD&D Coverage