Associate Director, Regulatory Affairs - CMC

POSITION DESCRIPTION

Job Title: Associate Director, Regulatory Affairs CMC

Reports to: Senior 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.