Manager, Regulatory, EU (1 year contract)

Manager, Regulatory, EU (1 year contract)

Remote - Netherlands; Remote - UK

About BridgeBio Pharma, Inc.

BridgeBio is a biopharmaceutical company dedicated to discovering, developing, and delivering transformative medicines for patients living with genetic diseases and genetically defined cancers. Since our founding in 2015, we have built a diverse portfolio of more than 20 drug development programs, ranging from early discovery to late-stage clinical trials, across multiple therapeutic areas including precision oncology, cardiology, endocrinology, neurology, and renal disease. We have already achieved regulatory approval for three therapies and continue to advance promising science from academia into meaningful treatments for patients worldwide.

Who We Are

BridgeBio is a global biotechnology company with our Global Headquarters located in San Francisco, USA, and our International HQ located in Zug, Switzerland. Since establishing our European presence in 2021, we’ve been building empowered, high‑performing teams across countries — with experienced colleagues who move quickly, take ownership, and are fueling the company’s international growth.

At BridgeBio, you’ll find an energetic and collaborative culture where pragmatism meets bold decision‑making. We embrace uncertainty with confidence, guided by our commitment to making a meaningful impact for patients. Our people are trusted and empowered, united by urgency, purpose, and the drive to advance science for patients around the world.

You will report to the VP, Regulatory Affairs, International, and work closely with the EU Regulatory Lead, the International team, and relevant cross-functional stakeholders in the US to drive strategic initiatives that support BridgeBio’s mission of delivering transformative medicines to patients with genetic diseases and genetically driven cancers. Your primary purpose will be to support the preparation, compilation and submission of an EU Marketing Authorization Application (MAA) for a small molecule orphan medicinal product. Working closely with the EU Regulatory Lead and cross‑functional teams, the focus will be on critical submission activities with primary responsibility for eCTD module 1 preparation, EU label development and handling of all aspects of regulatory information management in Veeva RIM. This role requires effective collaboration with cross‑functional colleagues and external stakeholders to ensure high‑quality execution and impact. The ideal candidate combines deep expertise in major EU regulatory submissions, including hands‑on preparation and filing responsibilities of an EU MAA with strong communication skills, adaptability, and the ability to thrive in a fast‑paced, hands‑on environment.

Where You’ll Work

If you are UK or Netherlands based : This is a fully remote role with occasional travel to our Switzerland Office.

Responsibilities

• Support preparation, compilation, and submission of EU regulatory filings across multiple products and procedures.
• Execute eCTD Module 1 authoring, compilation, and QC, including :
• –eAF creation and validation
• –ensuring QRD compliance of SmPC / PL / labeling
• –Manufacturing authorizations, QP declarations, ODD documentation
• Manage regulatory data, metadata, records, and workflows in Veeva RIM, ensuring accuracy, compliance, and inspection readiness.
• Coordinate timely submissions via EMA portals (IRIS, SPOR, OMS, Eudralink, etc.).
• Compile, review, and perform quality checks for Module 1 components, including creation and validation of eAFs.
• Ensure all submission packages meet regional requirements and internal quality standards prior to dispatch.
• Collaborate with cross‑functional teams (Regulatory, CMC, Clinical, Quality) to gather and verify required documentation.
• Maintain submission records and monitor timelines to support efficient regulatory lifecycle management.

Who You Are

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.

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