Senior Director/Vice President, Regulatory Affairs presso Korro Bio
Korro Bio · Cambridge, Estados Unidos De América · Hybrid
- Ufficio in Cambridge
Company Summary: Korro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform. Korro is generating a portfolio of differentiated programs that are designed to harness the body’s natural RNA editing process to effect a precise yet transient single base edit. By editing RNA instead of DNA, Korro is expanding the reach of genetic medicines by delivering additional precision and tunability, which has the potential for increased specificity and improved long-term tolerability. Using an oligonucleotide-based approach, Korro expects to bring its medicines to patients by leveraging its proprietary platform with precedented delivery modalities, manufacturing know-how, and established regulatory pathways of approved oligonucleotide drugs. Korro’s lead program is Alpha-1 Antitrypsin Deficiency (AATD). Korro is based in Cambridge, Massachusetts.
We are collaborative and united by a common mission. We are building a company with extraordinary people with an audacious vision to create transformative genetic medicines for prevalent diseases. Our values - Rewrite the future, On the Cutting Edge, Better Together, Dynamically Different, Kindness and Integrity form the fabric of the organization. They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Korro is a magnet for outstanding talent and a great place to work. Join us as we redefine what's possible in genetic medicine and work to make a lasting impact on human health.
Position Summary:
The Senior Director/Vice President of Regulatory Affairs will serve as the strategic and operational leader responsible for developing and executing global regulatory strategies to support clinical development, registration, and commercialization of the company’s pipeline. This individual will provide leadership and direction to internal teams and external partners, ensuring regulatory compliance and fostering effective interactions with global health authorities. Reporting to the Chief Scientific Officer, this position will work in close partnership with the VP of Clinical Operations, VP of Clinical Development and VP Research & Preclinical to ensure seamless execution of Korro's preclinical and clinical regulatory strategy.
Key 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.
Regulatory Strategy and Leadership:
Regulatory Operations and Submissions:
Cross-Functional Collaboration and Leadership:
Qualifications:
- Advanced degree (PharmD, PhD, MD, or MS) in life sciences or related field.
- 12+ years of progressive regulatory affairs experience in the biopharmaceutical industry, including leadership of regulatory strategy and submissions.
- Successful track record of interactions with FDA and global agencies, and experience leading major submissions (INDs, NDAs, BLAs, MAAs).
- Experience across multiple phases of development (preclinical through post-approval) strongly preferred.
- Deep understanding of global regulatory frameworks and guidelines.
- Proven ability to lead cross-functional initiatives and manage complex regulatory programs.
- Strong communication and interpersonal skills, with executive presence.
- Ability to thrive in a fast-paced, dynamic, and science-driven environment.
- Strategic thinker with operational excellence.
- High integrity and credibility with regulators and internal stakeholders.
- Collaborative leadership style with strong influencing skills.
- Entrepreneurial mindset and comfort operating in an emerging biotech setting.
Education & Experience:
Skills & Competencies:
Personal Attributes:
Benefits: Korro offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance, a dependent care flexible spending account and a Company-funded health savings account and free parking.
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