Senior Director, Global Regulatory Affairs Labeling

Summary

Join BridgeBio as a Sr. Director, Global Regulatory Affairs Labeling and collaborate with regulatory teams to develop and implement global labeling strategies. You will partner with various departments, lead the Label Working Group, and provide regulatory expertise. Responsibilities include overseeing labeling documents, maintaining awareness of global regulatory environments, developing best-in-class labeling processes, and advising on CCDS and local labeling deliverables. The ideal candidate possesses a Bachelor's degree in a relevant field, 10+ years of pharmaceutical experience, including 3+ years in a leadership role, and strong knowledge of US and EU labeling requirements. BridgeBio offers a competitive compensation and benefits package, including flexible PTO, rapid career advancement, and access to learning and development resources.

Requirements

• Bachelor’s Degree in Pharmacy, Biology, Chemistry or Microbiology, or related field
• 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%

Responsibilities

• Provide regulatory expertise and guidance to internal stakeholders for successful development and implementation of global regulatory labeling strategy and documentation
• Collaborate closely with BridgeBio regulatory teams and subject matter experts to implement regulatory strategies and oversight of global labeling activities
• Partner with Regulatory Affairs, Medical Affairs, Legal, Clinical Development, Commercial and International distributors and lead the Label Working Group
• Input to requirements for tools and systems for the compliant management of labeling documents to ensure that work is performed in accordance with established procedures and GxPs
• Maintain awareness of global regulatory environments and assess the impact of changes on product labeling activities throughout development and commercialization
• Provide strategic interpretations of labeling regulations and guidelines in a range of markets, including the US and EU. This can be accomplished by managing and utilizing local resources (e.g., in-country or in-region labeling consulting services)
• Develop, improve, implement, and document best-in-class labeling processes, metrics, and templates, including influencing stakeholders at all levels to ensure that good labeling process is followed throughout the product lifecycle
• Directly oversee and provide strategic and tactical advice for the maintenance and development of CCDS and local labeling deliverables for regulatory filings
• Monitor consistency between local labeling documents and CCDS, and ensure exceptions are documented through standard process
• Review and approve all change requests for revised labeling for assigned products
• Prepare labeling strategic plans and participate in label related Health Authority negotiations
• Review final artwork to be implemented into production

Preferred Qualifications

Relevant Master’s degree preferred. Certification in regulatory affairs a plus

Benefits

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to 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 de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
• A place where you own the vision – both for your program and your own career path
• A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
• Access to learning and development resources to help you get in the best professional shape of your life
• Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
• Flexible PTO
• Rapid career advancement for strong performers
• Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time
• Partnerships with leading institutions
• Commitment to Diversity, Equity & Inclusion