Vice President, US Regulatory Affairs

ITF Therapeutics•Concord, MA

About The Position

The Vice President of Regulatory Affairs is a senior leadership role responsible for leading and developing all US regulatory activities for ITF Therapeutics’ rare disease portfolio, including marketed and pipeline products. The role leads US regulatory strategy, manages FDA interactions, and ensures compliance with relevant regulations and post-market safety reporting requirements. Reporting to the President, ITF Therapeutics, the Vice President serves on the executive management team, builds and leads a high-performing US Regulatory Affairs organization, and partners strategically with Global Regulatory Affairs. The position oversees regulatory strategy, FDA engagement, regulatory submissions, compliance, pharmacovigilance operations, and regulatory intelligence. It also leads a US Regulatory team spanning Regulatory Strategy, Regulatory CMC, Regulatory Publishing, and Advertising and Promotion, and collaborates across functions and regions to support product development and lifecycle management.

Requirements

15+ years of demonstrated growth and proven success leading regulatory strategy, preparing high-impact submissions, and negotiating labels.
Direct experience with FDA interactions and regulatory filings.
Familiarity with rare diseases, small molecules, and large molecules.
Thorough knowledge of FDA regulations for investigational products, IND/NDA/BLA submissions, and in-line product lifecycle management.
Awareness of major global regulatory frameworks, such as EMA, ICH, and MHRA, and demonstrated contribution to worldwide regulatory strategy.
Experience in global corporate environments and ability to navigate and collaborate across matrixed international organizations.
Strong scientific writing and strategic thinking.
Deep understanding of FDA regulations and CTD/eCTD formats.
Ability to lead cross-functional teams and manage external partners in a matrixed organization.
Hands-on, proactive, and adaptable approach in a fast-paced, growth-phase biotech environment.

Nice To Haves

Advanced scientific degree desired (PhD, PharmD, MS, or MSN).

Responsibilities

Lead development and implementation of US regulatory strategies in alignment with Global Regulatory Affairs.
Contribute to global regulatory strategy development and ensure effective regional implementation.
Provide regulatory and pharmacovigilance leadership across product development stages and translate regulatory context into actionable business strategies.
Lead US regulatory strategy and FDA engagement, including scientific advice, label negotiations, submissions, lifecycle management, and maintenance of relevant operating licenses.
Serve as the executive interface with the FDA for ITF Therapeutics’ marketed and pipeline products.
Plan and execute regulatory agency engagements, inspections, and communications.
Ensure ongoing FDA compliance, including advertising, promotion, post-market obligations, and pharmacovigilance requirements.
Oversee regulatory submissions, including INDs, NDAs, label updates, OPDP Forms, and periodic reports.
Monitor the regulatory environment, share regulatory intelligence with US and global leadership, and maintain internal guidelines.
Oversee pharmacovigilance operations, including adverse event reporting, signal detection, risk management plans, and safety updates with Global Safety counterparts.
Ensure alignment of local operating standards with Global GxP standards and governance frameworks.
Build, lead, and develop the US Regulatory team, including Regulatory Strategy, Regulatory CMC, Regulatory Publishing, and AdProm capabilities.
Serve as an organizational leader and steward of corporate values and culture.
Build strategic collaboration with Global Regulatory Affairs and Development functions.
Collaborate with Medical Affairs, Marketing, Legal, Clinical Operations, and other cross-functional partners.
Partner with the VP Global Regulatory Affairs to align regional and global priorities.
Contribute to business development and due diligence by assessing regulatory options, risks, and opportunities for candidate products.