Executive Director, Regulatory Affairs

About Third Harmonic Bio

Third Harmonic Bio is a biopharmaceutical company with a singular purpose: To create a breakthrough treatment for people living with severe allergy and inflammation - debilitating conditions that can take a significant toll on overall health and well-being.

We are developing a highly selective oral wild-type KIT inhibitor for millions of people living with chronic urticaria, severe asthma, and other mast cell-mediated diseases. Despite the availability of multiple approved medicines, there is an urgent need for new treatment options. We are grounded in our purpose of developing medicines to meaningfully improve the lives of the patients we serve.

We are seeking smart, fun, and talented individuals seeking a fast-paced environment where they can meaningfully contribute to building a successful company.

Our Values

Our values provide the foundation for our culture and our operating principles - and underly how we hold ourselves accountable and how we interact with each other, with our partners, and with the global medical and patient community.

Be Human

Relationships are important. Bring your full self to work and create space for others to do the same. Balance candor with empathy.

Own the Big Picture

Context is critical. Ground every decision and action in the entirety of what we are trying to achieve.

Go THRD

We hold ourselves to a higher standard. Work with urgency, purpose, and passion.

The Role

Reporting to the Chief Development Operations Officer, the Executive Director, Regulatory Affairs will lead the Regulatory Affairs function and drive development and execution of regulatory strategies for THRD products. This role provides a unique opportunity to build and lead a function at a fast-paced, dynamic, growing company

Responsibilities

• Develop and execute regulatory strategies for THRD products, ensuring alignment with cross-functional stakeholders, as well as, corporate objectives and regulatory requirements

• Serve as regulatory leader for health authority interactions related to product development across programs

• Oversee all agency regulatory interactions, including the preparation of clinical trial (IND, CTA) and marketing (BLA, MAA) applications, and management of interactive meetings.

• Represent regulatory position and issues in senior leadership discussions and present solutions accordingly

• Drive decision-making across the organization with respect to regulatory issues, strategies and hiring; collaborate and influence stakeholders cross-functionally

• Proactively identify issues that will impact programs and provide strategies to address them and mitigate risk; communicate solutions to the project teams and leadership

• Provide insight and guidance on implementation of regulations for the preparation and submission of regulatory documentation, including the design of clinical trials

• Monitor changes in regulations, guidelines, and industry trends to anticipate potential impacts on our products, operations and develop proactive strategies to address them, consistent with the company's interests

• Lead and mentor a team of regulatory professionals, providing guidance, support, and professional development opportunities to foster a high-performance culture

• Develop a vision for department growth, to include all aspects of regulatory affairs, including Regulatory CMC and Regulatory Operations

Minimum Qualifications

• BS/BA in a scientific or healthcare-related field; advanced degree preferred

• 15+ years biopharmaceutical industry experience, including 8+ years in Regulatory Affairs

• Experience working with and productively influencing all levels of management and consulting with key business stakeholders.

• Strong enterprise leader with the ability to shape and communicate a strategy to internal and external stakeholders

• Leadership experience, with the ability to inspire and motivate a team to achieve goals and drive results

• Strong communication skills, capability to make compelling presentations and influence key stakeholders; high interpersonal skills, ability to connect and work with others

• Must love fast-pace, working in an environment that makes data-based decisions quickly

• Ability to thrive in a startup environment, with a passion for innovation and a willingness to take on new challenges

The base salary range for this role is: $275,000-$320,000

All qualified applicants will receive consideration for employment without regard to race, sex color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.