VP, US Regulatory Affairs & Rare Disease Strategy

ITF Therapeutics LLC; Concord (MA); On-site; USD 330,000 - 370,000; Full time

Job summary

ITF Therapeutics LLC seeks a Vice President of Regulatory Affairs to direct US regulatory strategy for our rare disease portfolio in Concord, MA. You will lead FDA interactions, submissions, and lifecycle management while reporting to the President and building a top-tier US Regulatory Affairs team.

Collaborate with Global Regulatory Affairs, Development, Medical Affairs and Legal to align regional and global priorities, ensure compliance, and optimize patient access across programs.

Qualifications

• PhD/PharmD/MS/MSN or equivalent advanced degree.
• 15+ years leading regulatory strategy and FDA engagement.
• Deep knowledge of FDA regulations for INDs/NDAs/BLAs.
• Experience with global regulatory frameworks (EMA, ICH, MHRA).
• Proven ability to manage cross-functional global programs.

Responsibilities

• Lead US regulatory strategy for rare disease portfolio.
• Manage FDA interactions, submissions, and lifecycle maintenance.
• Oversee US Reg Affairs team including publishing and CMC.
• Ensure compliance with FDA regulations and post-market obligations.
• Collaborate with Global Regulatory Affairs and Development.
• Engage with authorities and guide strategic regulatory decisions.

Skills

Regulatory strategy

FDA interactions

Life cycle management

Regulatory submissions

Cross-functional leadership

Global regulatory frameworks

Pharmacovigilance coordination

Strategic writing

Education

PhD/PharmD/MS/MSN

Job description

ITF Therapeutics LLC seeks a Vice President of Regulatory Affairs to direct US regulatory strategy for our rare disease portfolio in Concord, MA. You will lead FDA interactions, submissions, and lifecycle management while reporting to the President and building a top-tier US Regulatory Affairs team.

Collaborate with Global Regulatory Affairs, Development, Medical Affairs and Legal to align regional and global priorities, ensure compliance, and optimize patient access across programs.