Director • Lead

Who you are

You have a strong background in regulatory affairs, with a proven track record of developing and executing regulatory strategies for early-stage and advanced therapy products. Your experience includes preparing key submissions and ensuring alignment with both U.S. and international regulatory requirements. You are adept at monitoring and interpreting evolving regulatory landscapes, which allows you to engage effectively with external stakeholders and contribute to industry workgroups that inform development pathways. You possess excellent communication skills and can build internal regulatory intelligence resources to support your team.

You thrive in collaborative environments, partnering cross-functionally to guide successful progression through pre-IND/CTA stages and the product lifecycle. Your leadership style fosters trust and accountability, and you are committed to innovation in the regulatory space. You understand the importance of regulatory compliance in the development of therapies that can significantly impact patients' lives.

Desirable

Experience in gene therapy or cell therapy is a plus, as is familiarity with global regulatory frameworks. You are comfortable navigating complex regulatory environments and have a network of contacts within regulatory agencies that can facilitate communication and collaboration. A background in scientific research or a related field can enhance your understanding of the products you will be working with.

What you'll do

As the Director of Regulatory Affairs, you will be responsible for developing and executing comprehensive regulatory strategies that align with the company's goals for its advanced therapy products. You will prepare and submit regulatory filings, ensuring that all submissions meet the necessary requirements and are delivered on time. Your role will involve continuous monitoring of regulatory changes and trends, allowing you to adapt strategies as needed to maintain compliance and facilitate product development.

You will engage with regulatory agencies and external stakeholders to advocate for the company's interests and ensure that the regulatory pathway is clear and achievable. This includes participating in meetings with regulatory bodies and presenting data and strategies that support the approval of products. You will also contribute to industry workgroups, sharing insights and collaborating with peers to shape best practices in regulatory affairs.

In addition to your regulatory responsibilities, you will build and maintain internal resources that provide regulatory intelligence to the broader organization. This will involve creating training materials and conducting workshops to ensure that all team members understand the regulatory landscape and its implications for their work. You will work closely with cross-functional teams, including R&D, quality assurance, and clinical operations, to ensure that regulatory considerations are integrated into all stages of product development.

What we offer

At Regenxbio, you will be part of a mission-driven organization that values trust, accountability, perseverance, and innovation. We offer a collaborative work environment where you can engage with some of the brightest minds in the industry. You will have the opportunity to make a significant impact on the development of therapies that can change patients' lives. We provide competitive compensation and benefits, along with opportunities for professional growth and development within the company. Join us in our commitment to advancing science and improving patient outcomes.