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.

To learn more about our story and company culture, visit us at https://bridgebio.com

What You'll Do

You will report to

the

VP, Regulatory Affairs, International,

and work closely with

the EU

Regulatory

Lead

, th

nternational

team,

and relevant

cross functional

stakeholders in the US

to drive strategic initi

atives that

support

BridgeBio’s

mission of delivering transformative medicines to patients with genetic diseases

and genetically driven cancers

. Your primary purpose will be to

suppo

the prep

aration

compilation

and submission

Marketing Authorization Application

(MAA)

for a small molecule

orphan medicinal product.

Working closely with the EU Regulatory Lead and cross-functional teams

, t

he focus will be

critical submission activities with primary responsibility for

eCTD module 1 pr

eparation,

EU label

development

and

handling of all

aspects

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 cand

idate com

bines deep

expertise

major

EU regulatory submissions, including hands-on preparation and filing responsibilitie

s 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 acrossmultiple products and procedures.
executeeCTDModule 1 authoring, compilation, and QC, including:
–eAFcreation and validation
–ensuring QRD compliance ofSmPC/PL/labelling
– Manufacturingauthorisations, 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

5–8 years of experience supporting EU regulatory submissions, including hands-on preparation and filing responsibilities of major EU submissions (EU MAA preferred)
Strong proficiency with Veeva RIM for managing submissions, regulatory information and document workflows
Working knowledge of EMA systems (IRIS, SPOR, and other submission portals)
Demonstrated expertise in compiling and reviewing eCTD Module 1 documentation and completing eAFs
Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field (Master’s preferred)
Excellent attention to detail with the ability to manage multiple priorities under tight timelines
Strong communication and collaboration skills, with experience working in cross-functional regulatory environments
Willingness to travel to the Zug, Switzerland office quarterly or as needed

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. 

Market leading compensation 
Hybrid work model - we value your flexibility in how you work, but encourage time in the office to strengthen our culture, collaboration, and sense of community
We provide career development through regular feedback, continuous education and professional development programs
We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

Manager, Regulatory, EU (1 year contract)

Meet JobCopilot: Your Personal AI Job Hunter