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