Vice President, US Regulatory Affairs

Reports To: President, ITF Therapeutics
Location: Concord, MA

About This Role:

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 both marketed and pipeline products. This individual will lead US regulatory strategy, manage all FDA interactions, and ensure compliance with relevant regulations and post-market safety reporting requirements.  This individual will report to the President, serve as a key member of the executive management team, build and lead a high-performing US Regulatory Affairs organization, and act as a strategic partner to Global Regulatory Affairs.
What You'll Do:

Strategic Leadership

• Lead development and implementation of US regulatory strategies in close alignment with Global Regulatory Affairs 

• Contribute to Global regulatory strategy development and ensure effective regional implementation of Global strategy

• Provide expert Regulatory and Pharmacovigilance leadership across product development stages and translate regulatory context into actionable business strategies that optimize impact for the patient communities we serve 

• Be responsible for US Regulatory strategy and all FDA engagement including scientific advice, label negotiations, submissions, lifecycle management, and maintenance of all relevant operating licenses.

Regulatory Engagement & Compliance

• Nurture a collaborative relationship with regulatory authorities and serve as the executive interface for all FDA for ITF Therapeutics’ in-line and pipeline products  

• Lead planning and execution of regulatory agency engagements, inspections, and communications

• Ensure ongoing compliance with FDA regulations, including advertising, promotion, post-market obligations, and pharmacovigilance requirements

• Oversee all regulatory submissions (INDs, NDAs, label updates, OPDP Forms, periodic reports, etc.)

• Monitor regulatory environment, share regulatory intelligence with US & Global leadership to inform decisions, and maintain internal guidelines accordingly to ensure compliance

• Oversee pharmacovigilance operations, including adverse event reporting, signal detection, risk management plans, and safety updates in collaboration with Global Safety counterparts

• Ensure alignment of local operating standards with Global GxP standards and governance frameworks

Team Leadership

• Build, lead, and develop a best-in-class US Regulatory team including Regulatory Strategy, Regulatory CMC, Regulatory publishing, and AdProm capabilities.

• Serve as an organization leader and be a steward of corporate values and culture

• Build a high impact strategic collaboration with Global Regulatory Affairs and Development functions 

Cross-Functional Collaboration

• Work closely with Medical Affairs, Marketing, Legal, Clinical Operations, and other cross functional partners to optimize the impact of our products for the patient communities we serve

• Serve as partner with VP Global Regulatory Affairs to enable alignment across regional and global priorities
• Contribute to business development and due diligence efforts by assessing regulatory options, risks, and opportunities for candidate products

Required Skills:

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

• 15+ years of demonstrated growth and proven success leading regulatory strategy, preparing a high impact submission, and negotiating winning labels
• Direct experience with FDA interactions and regulatory filings
• Familiarity with rare diseases, small and large molecules
• Thorough knowledge of FDA regulations for investigational products, IND/NDA/BLA submissions, and in-line product life cycle management   
• Awareness of major global regulatory frameworks (e.g. EMA, ICH, MHRA) and demonstrated contribution to worldwide regulatory strategy 
• Experience working in global corporate environments and demonstrated 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 in a fast-paced growth-phase biotech environment

Additional Information:

The base compensation range for this role is: $330,000.00-$370,000.00. Compensation is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.