Manager, Regulatory, EU (1 year contract)

BridgeBio Pharma(1 month ago)

HybridFull TimeSenior$155,327 - $206,818 (estimated)Regulatory Affairs

About this role

The role supports preparation, compilation, and submission of EU regulatory filings, with primary responsibility for eCTD Module 1 and EU Marketing Authorization Application activities for a small-molecule orphan product. The position reports to the VP, Regulatory Affairs, International and works closely with the EU Regulatory Lead and cross-functional teams to drive strategic initiatives and ensure regulatory compliance and inspection readiness. The role is hands-on and requires collaboration with internal and external stakeholders across regions.

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Required Skills

eCTD Authoring
eAF Creation
QRD Compliance
Label Development
Manufacturing Authorisations
Veeva RIM
EMA Portals
Module Compilation
Quality Control
Regulatory Submissions

+2 more

Qualifications

Bachelor's Degree in Life Sciences, Pharmacy, or Regulatory Affairs
Master's Degree Preferred

About BridgeBio Pharma

bridgebio.com

BridgeBio 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.