Senior Director, Global Regulatory Affairs - Labeling

November 21, 2024

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BridgeBio

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BridgeBio is a biotechnology company focused on designing transformative medicines for patients with genetic diseases. It employs a novel approach to drug development by integrating finance with science to deliver solutions as efficiently as possible. The company is committed to developing not only life-changing drugs but also leaders in the field, encouraging hands-on engagement and the pursuit of innovation. BridgeBio actively seeks investment to help achieve its mission of providing solutions for unique patient populations with unmet needs. Headquartered in Palo Alto, CA, BridgeBio emphasizes bridging the gap between scientific advancements and patient care.

201 - 500 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• The Sr. Director, Global Regulatory Affairs Labeling collaborates with BridgeBio regulatory teams and is a subject matter expert to support the development and implementation of regulatory labeling strategies. • The incumbent will partner with various departments including Regulatory Affairs, Medical Affairs, Legal, Clinical Development, Commercial, and International distributors to lead the Label Working Group. • Work creatively and independently to support and facilitate cross-functional efforts to meet company goals across BridgeBio affiliates as needed.

🎯 Requirements

• Required Education: Bachelor’s Degree in Pharmacy, Biology, Chemistry or Microbiology, or related field • Preferred Education: Relevant Master’s degree preferred. Certification in regulatory affairs a plus • Required Experience: 10+ years pharmaceutical, regulatory or industry-related experience. 8 years of pharmaceutical experience. Proven 3 years in a leadership role • Strong knowledge of US and EU product labeling requirements, regulations, and guidelines • Ability to create, revise, and update product labeling (e.g., CCDS, USPI, EU SmPC) for regulatory submissions • Excellent project management skills • Strong communication and relationship-building abilities • Knowledge of scientific principles and regulatory/quality systems relevant to drug development • Ability to interpret laws, regulations, and guidance documents • Travel – Up to 10%

🏖️ Benefits

• Patient Days, where we hear directly from individuals living with the conditions we impact throughout the year and learn how we can improve our efforts • A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak • An unyielding commitment to always putting patients first • A decentralized model enabling program teams to advance science and help patients • A place where you own the vision for your program and career path • A collaborative, fast-paced, data-driven environment where we inspire each other to perform at our best • Access to learning and development resources to help you professionally • Robust and market-competitive compensation and benefits package including base pay, performance bonus, equity, health, welfare and retirement programs • Flexible PTO • Rapid career advancement for strong performers • Potential to work on multiple BridgeBio Pharma programs across therapeutic areas • Partnerships with leading institutions • Commitment to Diversity, Equity & Inclusion