VP, US Regulatory Affairs — Rare Disease Strategy Leader

ITF Therapeutics LLC; Concord (MA); Sur place; USD 330 000 - 370 000; Plein temps

Résumé du poste

ITF Therapeutics LLC in Concord, MA is seeking a Vice President of Regulatory Affairs to lead US regulatory strategy for the rare disease portfolio, manage FDA interactions, and ensure post-market safety reporting.

This executive will build and lead the US Regulatory Affairs organization, collaborate with Global Regulatory Affairs, and advise on lifecycle management, submissions (INDs/NDAs), and cross-functional risk planning.

Qualifications

• 15+ years of regulatory leadership experience.
• Direct FDA interactions and regulatory submissions.
• Experience with rare diseases and life-cycle management.
• Familiarity with EMA/ICH/MHRA regulatory frameworks.
• Strong scientific writing and strategic thinking.

Responsabilités

• Lead US regulatory strategy and FDA engagement for US portfolio.
• Oversee regulatory submissions (INDs, NDAs, label updates) and lifecycle management.
• Build and lead US Regulatory Affairs team, collaborating with Global Regulatory Affairs.
• Ensure compliance with FDA regulations including pharmacovigilance.
• Collaborate with Medical, Legal, Marketing and Clinical Operations.
• Provide strategic regulatory guidance across product development stages.

Connaissances

Regulatory strategy

FDA interactions

Pharmacovigilance

Scientific writing

Cross-functional leadership

Formation

Advanced scientific degree (PhD/PharmD/MS/MSN)

Outils

CTD/eCTD knowledge

Description du poste

ITF Therapeutics LLC in Concord, MA is seeking a Vice President of Regulatory Affairs to lead US regulatory strategy for the rare disease portfolio, manage FDA interactions, and ensure post-market safety reporting.

This executive will build and lead the US Regulatory Affairs organization, collaborate with Global Regulatory Affairs, and advise on lifecycle management, submissions (INDs/NDAs), and cross-functional risk planning.