Director/Sr. Director Regulatory Affairs

Who you are

You have extensive experience in regulatory affairs, ideally with a focus on drug development and registration. Your background includes leading post-marketing regulatory activities and managing lifecycle changes for approved products. You are proactive and possess a deep understanding of global regulatory requirements, enabling you to navigate complex landscapes effectively. Your leadership style encourages collaboration and innovation, and you thrive in environments that challenge conventional approaches. You are someone who is not afraid to ask 'why not?' and seeks to drive impactful change in the biopharma industry.

Desirable

Experience in a fast-paced pharmaceutical environment is a plus, as is familiarity with lifecycle management of approved products. You may also have a background in rare diseases or innovative drug development approaches, which would enhance your ability to contribute to our mission.

What you'll do

As the Director/Sr. Director of Regulatory Affairs, you will lead the global regulatory strategy for BridgeBio, overseeing all stages of drug development and registration. Your role will involve both high-level strategic oversight and hands-on involvement in regulatory submissions. You will be responsible for leading post-marketing regulatory activities, including lifecycle management of approved products and related amendments. You will work closely with cross-functional teams to ensure compliance with regulatory requirements and to facilitate timely submissions. Your expertise will guide the organization in navigating the complexities of global regulatory landscapes, ensuring that our innovative therapies reach patients as quickly as possible.

What we offer

At BridgeBio, we offer a competitive salary range of $255,000—$315,000 USD, reflecting the importance of this role in our organization. You will have the opportunity to work alongside some of the most respected minds in the industry, contributing to groundbreaking advancements in rare disease treatment. We foster a culture of innovation and collaboration, where your ideas and expertise will be valued. Join us in our mission to develop life-changing medicines for patients with unmet needs, and be part of a team that is redefining the future of biopharma.