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AD/Director, Regulatory Affairs CMC at BridgeBio

Department: Regulatory AffairsEducation: education_required

Compensation

$190,000 – $285,000/yr

Setup
Remote
Type
Full-time
Level
lead/mgmt
Posted

Description

BridgeBio is hiring an Associate Director/Director, Regulatory Affairs CMC for a U.S.-based remote role with quarterly or as-needed visits to the San Francisco office. The position develops global CMC regulatory strategies, prepares CMC sections of regulatory dossiers and marketing applications, manages author, review, and approval workflows, supports health authority interactions, and maintains knowledge of global drug-development and product-registration regulations. Candidates need a bachelor’s degree, at least seven years of pharmaceutical or related regulatory, CMC, drug-development, manufacturing, quality-control, or quality-assurance experience, strong communication and project-management skills, computer proficiency, and the ability to use artificial intelligence tools. The role offers a $190,000–$285,000 USD salary range for California-based candidates and includes medical, dental, vision, HSA, FSA, equity, and other benefits.

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