Senior Director, Global Regulatory Affairs - Labeling

2 hours ago

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BridgeBio

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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