Manager, Regulatory, International Markets (MENA) (1 year contract)

AI overview

Manage the preparation and submission of regulatory dossiers for international markets while leading a team to support submissions in MENA and ensuring compliance.

 

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

  • Prepare, compile, and support submission of regulatory dossiers for international markets, ensuring all Module 1 administrative components and GMP registration requirements are met
  • Coordinate, review, and quality-check administrative and technical documentation for new product registrations in MENA and other global regions
  • Manage regulatory documents and data within Veeva Vault RIM, ensuring accurate metadata, proper workflow routing, and compliance
  • Work closely with SMEs to gather required documentation as per country-specific regulations
  • Track and maintain submission status, timelines, and documentation in relevant systems to support efficient registration processes
  • Support preparation of responses to agency queries in collaboration with internal experts
  • Maintain organized records of international regulatory submissions and lifecycle documents

Where You'll Work

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

Who You Are 

  • 5–10 years of experience preparing and compiling regulatory dossiers for international markets, including M1 administrative requirements and GMP registration
  • Proven experience supporting registrations in MENA regions and other global territories
  • Strong proficiency with Veeva Vault RIM for document management, workflow execution, and metadata accuracy
  • Solid understanding of country-specific regulatory expectations and submission processes outside the EU and US
  • Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related discipline (Master’s preferred)
  • Excellent organizational skills with strong attention to detail and the ability to manage multiple concurrent submissions
  • Effective communication and collaboration skills across cross-functional and global teams

 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

 

Perks & Benefits Extracted with AI

  • Flexible Work Hours: 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
  • Financial rewards and recognition: We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 20+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs. Our focus on scientific excellence and rapid execution aim to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe. To learn more about our story and company culture, visit us at https://bridgebio.com

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