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Nuvalent, Inc. · 1 day ago

Vice President, Regulatory Affairs

United States

Full-time

Remote

Director/Executive

$315K/yr - $340K/yr

15+ years exp

Nuvalent is an exciting early-stage company focused on creating selective medicines for cancer patients. The Vice President of Regulatory Affairs will lead the development and execution of global regulatory strategies, oversee regulatory submissions, and manage interactions with health authorities to ensure compliance and efficient drug development.

BiotechnologyLife ScienceTherapeutics

Responsibilities

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

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

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

Ensure regulatory activities adhere to global standards and guidelines (ICH, FDA, EMA)

Monitor evolving regulatory landscapes and provide guidance on new expectations and opportunities

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

Qualification

Regulatory AffairsOncology ExperienceCDx DevelopmentGlobal SubmissionsExecutive CommunicationLeadership SkillsStrategic ThinkingMulti-taskingCross-Functional CollaborationAttention to Detail

Required

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

Benefits

Medical, dental, and vision insurance

401(k) retirement savings plan

Generous paid time off (including a summer and winter company shutdown)

Company

Nuvalent, Inc.

Nuvalent is creating precisely targeted therapies for patients with cancer designed to overcome the limitations of existing therapies for clinically proven kinase targets.

Founded in 2017

Cambridge, Massachusetts, USA

51-200 employees