Director, Regulatory Affairs

Orna Therapeutics; Watertown (MA); On-site; USD 100,000 - 160,000; Full time

Job summary

An innovative biotechnology startup is seeking a strategic Director of Regulatory Affairs to lead the development of regulatory strategies for groundbreaking RNA therapeutics. This pivotal role involves collaborating with cross-functional teams to ensure timely submissions and effective communication with regulatory authorities. The ideal candidate will have extensive experience in regulatory affairs, particularly with RNA-based therapies, and a strong understanding of FDA regulations. Join a forward-thinking company dedicated to transforming healthcare and making a significant impact on patient lives.

Qualifications

• 8+ years of regulatory affairs experience in biopharmaceuticals.
• Strong knowledge of FDA regulations and IND authorship.

Responsibilities

• Lead global regulatory strategies for pipeline programs.
• Prepare and submit key regulatory documents including INDs.
• Support regulatory interactions with the FDA and health authorities.

Skills

Regulatory Affairs Leadership

FDA Regulations Knowledge

Cross-Functional Collaboration

Project Management

Communication Skills

Education

Bachelor's degree in life sciences

PhD, PharmD, or MS

Job description

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 strategic and execution-focused Director of Regulatory Affairs to join our team and help advance our novel circular RNA therapeutics through key regulatory milestones. This individual will be responsible for leading the development and execution of regulatory strategies across Orna's pipeline, including IND-enabling activities, early clinical development, and CMC components. Reporting to the Chief Medical Officer, the Director will collaborate cross-functionally to ensure timely, high-quality submissions and effective interactions with regulatory authorities.

The ideal candidate will have a solid track record of regulatory leadership in early development programs and experience supporting innovative therapeutic platforms such as RNA, lipid nanoparticle, cell, or gene therapies. This is a critical role in supporting Orna's mission to deliver transformational RNA medicines to patients.

Key Responsibilities

• Lead the development and execution of global regulatory strategies for Orna's pipeline programs, ensuring alignment with clinical, CMC, and corporate objectives
• Drive the preparation and submission of key regulatory documents, including INDs, meeting packages, amendments, and annual reports
• Act as the primary regulatory representative on cross-functional development teams, providing strategic guidance and regulatory insights throughout the product lifecycle
• Support regulatory interactions with the FDA and other health authorities, including meeting planning, briefing documents, and response strategies
• Monitor evolving regulatory requirements and provide proactive assessments of risks, opportunities, and implications for program strategy
• Partner with internal teams and external consultants to ensure efficient and compliant regulatory execution
• Contribute to the development and scaling of regulatory infrastructure, systems, and best practices

Qualifications

• Bachelor's degree in life sciences or a related field; advanced degree (PhD, PharmD, or MS) preferred
• Minimum 8 years of experience in regulatory affairs within the biopharmaceutical industry, including 2-4 years in a strategic or leadership capacity
• Strong knowledge of FDA regulations and global regulatory requirements; IND authorship and regulatory agency interaction experience required
• Experience with RNA-based therapeutics, lipid nanoparticles, or other advanced modalities is highly desirable
• Ability to synthesize complex information into clear, actionable plans
• Strong communication and interpersonal skills with a track record of effective cross-functional collaboration
• Detail-oriented with strong organizational and project management abilities
• Comfortable working in a fast-paced, innovative biotech environment

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.