Director/Sr. Director Regulatory Affairs
BridgeBio Pharma(1 month ago)
About this role
The Director/Senior Director of Regulatory Affairs will lead global regulatory strategy and execution across all stages of drug development, registration, and lifecycle management. This senior leader provides both high-level strategic oversight and hands-on participation in regulatory interactions, submissions, and cross-functional alignment. The role operates in a fast-moving biopharmaceutical environment supporting late-stage development, product launch, and global compliance.
Required Skills
- Post-Marketing
- Lifecycle Management
- Labeling Updates
- Safety Variations
- Manufacturing Changes
- Regulatory Strategy
- Regulatory Meetings
- Agency Correspondence
- Clinical Trials
- Regulatory Leadership
+16 more
Qualifications
- Bachelor's Degree in Scientific Field
- MD
- PhD
- PharmD
- MS
About BridgeBio Pharma
bridgebio.comBridgeBio is a biotechnology company designing transformative medicines for patients with genetic diseases and cancers driven by clear genetic causes. The company advances programs from target discovery through clinical development, combining human genetics and translational science with rigorous clinical trials to create targeted therapeutics. BridgeBio builds a diversified portfolio of wholly owned and partnered programs across multiple modalities and uses a venture‑style operating model to accelerate and de‑risk development. Its mission is to translate genetic insights into precision medicines for patients with high unmet medical need.
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