Vice President, Regulatory Affairs

Vice President, Regulatory Affairs / Alliance Management

The Company:

With deep expertise in chemistry, Nuvalent is creating selective medicines to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.

The Role:

Reporting to the Chief Development Officer, the Vice President of Regulatory Affairs / Alliance Management will serve as a senior regulatory leader, responsible for developing and executing global regulatory strategies across the company’s pipeline in support of the Head of Regulatory Affairs. This role will oversee regulatory submissions, interactions with global health authorities, and long-term planning to ensure programs progress efficiently and compliantly from early development through approval and commercialization.

This is a highly strategic, hands-on role suited for an accomplished regulatory executive with deep oncology experience and a track record of successful global filings. This executive will also oversee alliance management with diagnostic partners, ensuring seamless integration of regulatory, clinical, and commercial objectives across co-development programs.

Key Responsibilities:

Global Regulatory Leadership & Strategy

• Support the expansion of the regulatory department outside the US (EU and other geographies), including organizational planning, resource allocation, and alignment of global regulatory processes.
• Develop and lead global regulatory strategies aligned with corporate and program goals.
• Serve as the primary regulatory voice at the executive level, providing guidance on risks, opportunities, and development pathways.
• Anticipate regulatory challenges and implement proactive solutions to enable efficient drug development.

Companion Diagnostics (CDx) Leadership

• Serve as the primary regulatory lead for strategic diagnostic partnerships; manage joint development plans, governance structures, and communication channels to ensure alignment and execution.
• Define and lead global strategies for CDx regulatory requirements, including co-development expectations, validation, submission pathways, and labeling impacts.
• Oversee all CDx regulatory strategy and submissions related to CDx development, including interactions with FDA CDRH and other diagnostic regulators in coordination with diagnostic partner, as appropriate
• Ensure coordinated communication among Nuvalent teams, CDx partners and health authorities.
• Ensure regulatory readiness for launch, including labeling, risk mitigation, and post-market planning.
• Negotiate and maintain collaborative agreements with diagnostic partners, ensuring compliance and shared objectives.

Health Authority Engagement

• Support the Head of Regulatory Affairs and development teams in preparing rapid, high-quality responses to health authority inquiries, ensuring accuracy, consistency, and strategic alignment.
• Lead interactions with FDA, EMA, and global regulatory agencies, including meetings, written communication, and briefing materials.
• Ensure timely, well-organized management of all health authority questions, follow-up items, and commitments.

Compliance & Governance

• Ensure regulatory activities adhere to global standards and guidelines (ICH, FDA, EMA).
• Monitor evolving regulatory landscapes and provide guidance on new expectations and opportunities.

Cross-Functional Collaboration

• Partner closely with Program Management, Clinical Development, CMC, Nonclinical, Medical, and Commercial functions to align regulatory plans with development strategies.
• Contribute to clinical trial design, endpoints, labeling strategies, and lifecycle planning.
  
  

Competencies Include:

• Strong written/oral communication skills.
• Ability to work independently and successfully in a matrix environment, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
• Ability to foster effective relationships and collaboration, motivate others, and influence without authority.
• Excellent attention to detail.
• Excellent organization, communication, and multi-tasking skills.
• Strong desire to contribute as a member of an engaged and collaborative cross-functional project development team.

Qualifications:

• 15+ years of regulatory affairs experience in biotech/pharma, with significant leadership in CDx or IVD development.
• Proven track record of successful regulatory submissions and approvals for CDx products, ideally in oncology.
• Expertise with major global submissions and late stage or approved programs
• Demonstrated success leading regulatory strategy for oncology therapeutics.
• Strong leadership, strategic thinking, and executive communication skills.

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted range below reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors. The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.