Executive Assistant • Lead

Who you are

You have extensive experience in regulatory affairs, particularly in the CMC (Chemistry, Manufacturing, and Controls) domain, and have successfully led teams in navigating complex regulatory landscapes. Your strategic mindset allows you to define and execute global CMC regulatory strategies that align with product development goals. You thrive in collaborative environments, working closely with cross-functional teams including CMC, Quality, Technical Operations, Clinical, and Regulatory Affairs to ensure high-quality submissions and enable product licensure.

You possess strong leadership skills, guiding your team through the intricacies of regulatory processes while fostering a culture of innovation and accountability. Your ability to communicate effectively with stakeholders at all levels ensures that regulatory strategies are understood and implemented effectively. You are driven by a passion for advancing biopharma and are committed to making a difference in the lives of patients with unmet needs.

Desirable

Experience in rare disease therapeutics or similar fields is a plus, as is familiarity with the ethical and thoughtful use of AI in regulatory processes. A background in leading regulatory submissions for both development and commercial products will set you apart.

What you'll do

As the Executive Director, Regulatory CMC, you will be responsible for providing strategic and operational leadership for global CMC regulatory activities. You will define regulatory CMC strategy and ensure that high-quality submissions are made in a timely manner. Your role will involve close collaboration with various departments to align regulatory strategies with product development and lifecycle management. You will lead your team in preparing and submitting regulatory documents, ensuring compliance with all relevant regulations and guidelines.

You will also be tasked with mentoring and developing your team, fostering an environment of continuous improvement and professional growth. Your leadership will be crucial in navigating the complexities of regulatory submissions and ensuring that BridgeBio remains at the forefront of innovation in biopharma. You will engage with regulatory agencies and stakeholders to advocate for the company's interests and facilitate the approval process for groundbreaking therapies.

What we offer

At BridgeBio, we offer a competitive salary range of $320,000—$350,000 USD, along with a comprehensive benefits package. You will have the opportunity to work remotely while being part of a mission-driven organization that values curiosity and experimentation. Join us in redefining the future of biopharma and making a meaningful impact on patients' lives.