Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on

In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.

Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.

EIDOS THERAPEUTICS, INC.

POSITION DESCRIPTION

Job Title: Associate Director/Director, Regulatory Affairs CMC

Reports to: Executive Director, Regulatory Affairs CMC

This regulatory professional will have demonstrated the ability to work independently under the direction of his/her manager. This individual will manage internal regulatory processes, prepare documents for regulatory submissions in compliance with global health authority regulations. In conjunction with regulatory affairs leadership, he/she will develop strong relationships, collaborate, and interact with various departments and levels of management, including interactions across BridgeBio subsidiaries. Furthermore, the successful candidate will have demonstrated knowledge of regulatory requirements and guidelines and be able to apply their knowledge to daily work, and as needed represent regulatory affairs CMC as part of an interdisciplinary team.

REMOTE – This is a U.S.-based role that will require quarterly, or as needed visits to our San Francisco Office.

Responsibilities include but are not limited to the following:

Develop global CMC regulatory strategies in collaboration with manager and CMC subject-matter experts to meet business objectives for the Eidos program

Collaborate with cross-functional teams (e.g. Regulatory Int.) to create and prepare CMC sections of regulatory dossiers marketing applications (ROW)

Help prepare and communicate timelines

Plan and coordinate preparation of the CMC sections

Manage the author, review and approval workflows

Provide recommendations to team on regulatory strategy as needed

Provide RA CMC support for Health Authority interactions, including coordination of drafting and reviewing meeting requests and briefing books.

Work with team on strategy and responses to Health Authority CMC questions (ROW)

Provide support from triage through finalization of regulatory responses

Provide input to team on regulatory strategy as needed

Maintain current knowledge of applicable global regulations, guidance and standards for drug development and product registration

Other duties as assigned.

Qualifications

A minimum of a bachelor’s degree is required (life sciences discipline preferred)

Minimum of 7 years experience in pharmaceutical or related industry in regulatory affairs, CMC or related function, eg, drug development/manufacturing/QC/QA (an equivalent combination of education and experience may be considered)

Excellent communication skills and attention to detail

Independently able to manage projects and deliver output in a timely manner with limited direction of manager

Excellent computer skills, e.g., Microsoft suite of applications/software and document management system such as Veeva

Demonstrated self-starter with the ability to take initiative, work independently, and proactively identify and execute tasks with minimal supervision.

Excellent interpersonal, active listening, and influencing skills

Demonstrated ability to leverage artificial intelligence tools to support and enhance the execution of complex tasks, improving efficiency, and decision-making quality.