Executive Director, Regulatory Affairs

Kyverna Therapeutics; United States; Remoto; USD 270.000 - 300.000; Tempo pieno

Vantaggi offerti da questo lavoro

Bonus

Stock plan

Benefits

Descrizione del lavoro

Kyverna Therapeutics seeks an Executive Director, Regulatory Affairs to lead global regulatory strategy from development through launch, interfacing with FDA, EMA, and other authorities. The role shapes labeling, risk mitigation, and lifecycle management while partnering with Clinical, CMC, Commercial, Market Access, and Legal teams.

The ideal candidate brings 15+ years in regulatory affairs, advanced therapy experience, and a proven track record of leading teams in a fast-paced environment.

Competenze

• 15+ years of progressive regulatory affairs experience in pharmaceutical/biotechnology with advanced therapy experience.
• Cell and/or gene therapy experience preferred; autoimmune disease experience highly preferred.
• Proven experience leading global regulatory strategies through late-stage development and approvals (BLA/MAA).
• Experience with labeling strategy development and negotiation and understanding of commercialization impacts.
• Deep knowledge of FDA regulations, ICH guidelines, and global regulatory frameworks; EMA and ex-US experience preferred.
• Strong executive communication skills with the ability to influence senior leadership and Board audiences.
• Demonstrated ability to lead and scale teams in a fast-paced, high-growth environment; supervisory experience preferred.
• Strategic mindset balancing scientific rigor, regulatory compliance, and commercial impact.

Mansioni

• Lead global regulatory strategy for Kyverna's development programs from early development through post-approval lifecycle management.
• Provide regulatory input to governance and portfolio decisions, including risk mitigation.
• Serve as primary senior regulatory interface with FDA, EMA, and other authorities.
• Lead and/or support key regulatory meetings (INTERACT, pre-IND, End-of-Phase, pre-BLA/MAA, etc.).
• Drive regulatory negotiation strategy including endpoints, comparability, and post-approval requirements.
• Own and drive labeling strategy from development through approval for commercial differentiation.
• Lead development of Target Product Profiles and alignment across Clinical, Regulatory, Commercial, and Market Access.
• Partner with Commercial, Medical Affairs, and Market Access to support launch readiness.

Conoscenze

Regulatory strategy

Global leadership

FDA/EMA engagement

Regulatory submissions

Team leadership

Cross-functional collaboration

Formazione

Bachelor's degree in a scientific discipline

Advanced degree preferred

Descrizione del lavoro

The Executive Director, Regulatory Affairs will provide strategic and operational regulatory leadership across Kyverna's cell therapy portfolio, with a focus on commercial readiness, labeling strategy, and health authority engagement.

The ideal candidate is a seasoned regulatory leader with deep experience in advanced therapies who can shape regulatory strategy from early development through approval and launch, while partnering closely with Clinical, CMC, Commercial, Market Access, and Legal teams.

The Executive Director will define and execute global regulatory strategy to support clinical development, registration, and commercialization of Kyverna's autoimmune cell therapies. The role requires the ability to translate scientific and clinical data into approvable, commercially viable labeling and to lead interactions with regulatory authorities, including FDA and global counterparts.

Title: Executive Director, Regulatory Affairs

Reports to: SVP, Chief Regulatory Officer

Location: Remote (West Coast hours preferred)

Responsibilities

• Lead global regulatory strategy for Kyverna's development programs, aligning clinical, CMC, and commercial objectives from early development through post-approval lifecycle management.
• Provide regulatory input to program governance, asset prioritization, and portfolio decisions, including scenario planning and risk mitigation.
• Anticipate and address regulatory challenges related to cell therapy development, manufacturing, comparability, and long-term follow-up.
• Serve as the primary senior regulatory interface with FDA, EMA, and other global health authorities.
• Lead and/or support key regulatory meetings, including INTERACT, pre-IND, End-of-Phase, pre-BLA/MAA, Advisory Committees, and post-marketing commitments.
• Drive regulatory negotiation strategy, including benefit-risk, endpoints, comparability, and post-approval requirements.
• Own and drive labeling strategy from early development through approval, ensuring labels support commercial differentiation, patient access, and lifecycle value.
• Lead development of Target Product Profiles (TPPs) and ensure alignment across Clinical, Regulatory, Commercial, and Market Access.
• Partner with Commercial, Medical Affairs, and Market Access to ensure regulatory decisions support launch readiness, promotional strategy, and payer engagement.
• Lead label negotiations with health authorities, balancing scientific evidence, regulatory expectations, and commercial objectives.
• Oversee and contribute to the preparation, review, and submission of INDs, CTAs, BLAs/MAAs, briefing packages, orphan drug applications, and other regulatory filings.
• Ensure submissions are high-quality, compliant, and strategically positioned.
• Maintain oversight of submission timelines, dependencies, and risk management, providing clear communication to senior leadership.
• Act as a strategic partner to Clinical Development, CMC, Research, Commercial, Legal, BD, and Alliance Management teams.
• Provide regulatory due diligence and strategic input for business development, in-licensing, out-licensing, and partnership opportunities.
• Oversee regulatory activities performed by CROs, consultants, and partners, ensuring quality and strategic alignment.
• Lead, mentor, and scale a high-performing regulatory team, fostering accountability, development, and a culture of collaboration.
• Establish and maintain regulatory policies, procedures, and infrastructure to support a growing, late-stage organization.
• Stay current on US and global regulatory intelligence and communicate key implications to stakeholders.

Requirements

• Bachelor's degree in a scientific discipline required; advanced degree preferred.
• 15+ years of progressive regulatory affairs experience in pharmaceutical or biotechnology, with significant advanced therapy experience.
• Cell and/or gene therapy experience preferred; autoimmune disease experience highly preferred.
• Demonstrated success leading global regulatory strategies through late-stage development and or approvals, ideally including BLA/MAA experience.
• Proven experience with labeling strategy development and negotiation, with strong understanding of commercialization impacts.
• Deep knowledge of FDA regulations, ICH guidelines, and global regulatory frameworks; EMA and ex-US experience preferred.
• Track record of effective engagement with FDA OTP and or divisions overseeing autoimmune or immune-mediated diseases.
• Strong executive communication skills with the ability to influence senior leadership and Board-facing audiences.
• Demonstrated ability to lead and scale teams in a fast-paced, high-growth environment. Prior supervisory experience preferred.
• Strategic mindset with the ability to balance scientific rigor, regulatory compliance, and commercial impact.

The national base salary range for this position is $270K-$300K annually. This salary range is an estimate of what we reasonably expect to pay for this position, and the actual salary may vary based on various factors that may include but are not limited to quality and length of experience, education, geographic location and alignment with market data. This position is also eligible for bonus, benefits, and participation in the company's stock plan.