Sr. Director, Global Regulatory Affairs Labeling

About BridgeBio

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

Who You Are

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

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

No matter your role at BridgeBio, successful team members are:

• Patient Champions, who put patients first and uphold strict ethical standards
• Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
• Truth Seekers, who are detailed, rational, and humble problem solvers
• Individuals Who Inspire Excellence in themselves and those around them
• High-quality executors, who execute against goals and milestones with quality, precision, and speed

Education, Experience & Skills 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%

What We Offer

• 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. Learn more about how we do this here
• 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