Orna Therapeutics is an innovative biotechnology startup based in Watertown, MA, committed to developing groundbreaking therapies for diseases that current approaches cannot address. With our pioneering circular RNA technology, developed at MIT, we are at the forefront of advancing the next generation of RNA therapeutics. Our state-of-the-art expression and delivery platform positions us to tackle complex diseases, including B cell-driven autoimmune disorders, B cell malignancies, sickle cell disease, and beyond.

We are seeking a Vice President of Regulatory Affairs to join our innovative team and accelerate novel drug candidates to approval. This role is responsible for the development and execution of regulatory strategy across all functions, including preclinical and clinical development, CMC, and eventual commercialization. The VP of Regulatory Affairs will lead the strategic direction and operational execution of global regulatory activities across all programs.

The ideal candidate will have a strong track record of successful regulatory submissions and approvals across a broad spectrum of drug modalities and therapeutic areas. Experience advancing RNA, lipid nanoparticle, cell and/or gene therapies is highly desirable. In addition, the successful candidate will have hands-on experience with Phase 1 regulatory interactions and filings across the United States, European Union, and Asia.

This role will report to the Chief Medical Officer and work cross-functionally across R&D, business development, and corporate strategy.

Key Responsibilities

• Drive global regulatory strategy and lead preparation of all regulatory filings and meeting packages (e.g., INDs, IMPD’s, CTAs, briefing documents, marketing applications).
• Oversee global regulatory development plans across all programs, ensuring alignment with clinical trial requirements and company milestones.
• Develop creative and competitive regulatory strategies that expedite development timelines, maximize approval potential, and proactively manage risk.
• Serve as the primary strategic contact with global regulatory authorities, establishing and maintaining collaborative and proactive relationships to support regulatory innovation and pathway clarity.
• Build and lead the internal regulatory team and infrastructure; manage and oversee external consultants and vendors.
• Partner with internal stakeholders (R&D, CMC, Clinical Operations, Corporate Strategy, Legal, etc.) to support regulatory aspects of clinical protocols, data submissions, publications, and corporate communications.
• Represent Orna’s regulatory perspective in external interactions, scientific consortia, and partnerships when appropriate.

Qualifications

• Minimum of 15 years of regulatory affairs experience in the biotechnology or pharmaceutical industry, including at least 8 years in leadership roles.
• Proven experience leading global regulatory submissions, including INDs/IMPD’s/CTAs, with Phase 1 regulatory experience across the US, EU, and Asia.
• Deep understanding of regulatory guidance, quality standards (GxPs), and global health authority expectations across therapeutic modalities, with emphasis on RNA, lipid nanoparticle, gene, or cell therapy platforms.
• Strong grasp of global regulatory frameworks, legislation, and approval pathways.
• Demonstrated success in building and leading high-performing regulatory teams and in managing external regulatory partners.
• Exceptional communication, negotiation, and strategic planning skills.
• Committed leadership style with the ability to mentor others and influence across levels and functions.

Why Orna?

At Orna Therapeutics, we’re more than just a workplace—we’re a community. We believe in fostering an environment where individuals can grow, thrive, and make a lasting impact on the future of healthcare. Join us as we revolutionize RNA therapeutics and make a difference in the lives of patients around the world.

Equal Employment Opportunity Statement

Individuals seeking employment at Orna Therapeutics are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation.