VP Regulatory Affairs
One Kendall Square, Building 600 Cambridge, MA 02139
R & D – Clinical /
Full-time /
Hybrid
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 main therapeutic area 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.
Key Responsibilities:
· Regulatory Strategy: Develop and implement global regulatory strategies to support the development, registration, and commercialization of RNA-based therapeutics across multiple rare and prevalent disease indications.
· Regulatory Submissions: Prepare, review, and submit regulatory documents to health authorities (e.g., INDs, CTAs, BLAs, MAAs) in accordance with regulatory requirements and timelines.
· Agency Interactions: Serve as the primary point of contact with regulatory agencies (e.g., FDA, EMA) and facilitate interactions, meetings, and negotiations to address regulatory questions and concerns.
· Compliance and Quality Assurance: Ensure compliance with regulatory requirements, guidelines, and standards governing the conduct of clinical trials and the manufacturing of investigational and commercial products.
· Labeling and Advertising: Oversee the development and review of product labeling, promotional materials, and advertising to ensure compliance with regulatory requirements and guidelines.
· Regulatory Intelligence: Monitor and analyze regulatory trends, guidelines, and developments to inform and adapt regulatory strategies and activities.
· Cross-Functional Collaboration: Collaborate closely with cross-functional teams, including Clinical Development, Clinical Operations, Medical Affairs, and Quality Assurance, to align regulatory activities with overall development plans and timelines.
· Risk Management: Identify potential regulatory risks and develop risk mitigation strategies to ensure timely approvals and successful product launches.
· Team Development: Build and mentor a high-performing regulatory affairs team, fostering a culture of excellence, collaboration, and continuous learning.
Qualifications:
· Advanced degree in life sciences or related field (PharmD, MD, PhD, or equivalent).
· Minimum of 8 years of experience in regulatory affairs within the biotech/pharmaceutical industry, with a focus on drug development and registration.
· Extensive experience with regulatory submissions (e.g., INDs, BLAs, MAAs) and interactions with health authorities (e.g., FDA, EMA).
· Prior experience in RNA therapeutics and rare disease indications is highly desirable.
· Strong understanding of global regulatory requirements and guidelines governing drug development, including GCP, GMP, and ICH guidelines.
· Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders at all levels.
· Meticulous attention to detail, with a focus on quality, accuracy, and compliance.
· Proven ability to work in a fast-paced, dynamic environment and adapt to changing priorities.
Why Join Korro Bio:
· Opportunity to be at the forefront of regulatory innovation in the development of RNA-based therapeutics for rare and common diseases.
· Collaborative and entrepreneurial work environment where innovation and creativity are encouraged and valued.
· Competitive compensation package including salary, bonus, equity, and benefits.
· If you are passionate about shaping the regulatory landscape for cutting-edge RNA therapeutics and thrive in a dynamic and fast-paced environment, we encourage you to apply for this exciting opportunity to join the Korro Bio team.
