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Korro Bio, Inc. · 3 hours ago

Senior Director/Vice President, Regulatory Affairs

Cambridge, MA

Full-time

Onsite

Director/Executive

$250K/yr - $350K/yr

12+ years exp

Korro Bio, Inc. is a biopharmaceutical company focused on developing a new class of genetic medicines using its proprietary RNA editing platform. The Senior Director/Vice President of Regulatory Affairs will lead the development and execution of global regulatory strategies to support the clinical development and commercialization of the company’s pipeline, ensuring compliance and effective interactions with health authorities.

BiotechnologyHealth CarePharmaceutical

Responsibilities

Develop and implement global regulatory strategies aligned with corporate objectives for preclinical, clinical, and commercial programs

Serve as the primary regulatory contact for internal teams and health authorities (FDA, EMA, MHRA, PMDA, etc.)

Lead preparation and submission of INDs/CTAs, BLAs/NDAs/MAAs, and other key filings

Anticipate and mitigate regulatory risks; provide proactive guidance on evolving regulatory landscapes

Lead and execute in a lean organization while demonstrating hands-on, strong, cross-functional leadership across the organization to drive regulatory objectives and outcomes

Contribute to corporate strategy and participate in executive-level decision-making

Oversee all regulatory submissions, ensuring completeness, accuracy, and compliance with applicable regulations

Manage regulatory documentation systems and ensure inspection readiness

Lead interactions with external consultants, CROs, and regulatory agencies

Oversee development of labeling, promotional materials, and product claims

Partner closely with Clinical Development, CMC, Nonclinical, and project teams to align regulatory strategies with development plans

Serve as a trusted advisor to senior leadership on regulatory implications of corporate decisions

Foster a culture of accountability and innovation

Provide regulatory input to support business development and partnership activities

Mentor and develop peers to support both operational excellence and career growth

Qualification

Regulatory strategyRegulatory submissionsGlobal regulatory frameworksCross-functional leadershipCommunication skillsEntrepreneurial mindsetStrategic thinkerCollaborative leadership