BridgeBio is hiring a
Senior Director

Summary

Join a dynamic team at BridgeBio as the Senior Director of Regulatory Affairs EU Lead. This role will involve high-level strategic planning and hands-on responsibilities to define product strategies and implement regulatory strategy for assigned products in the EU.

Requirements

• University Degree in Science or related discipline. A higher degree would be desirable, especially one specific to regulatory affairs
• Extensive knowledge and experience of working in one or more areas in regulatory affairs in the pharmaceutical industry or experience with a health authority for 10-15 years
• Ideally a combined mix of large company and small biotech
• Demonstrated leadership competencies in establishing clear direction and objectives; ability to simplify complex processes and foster an environment that brings out the best in people
• Pre-and post-product launch experience in key European markets
• Advanced knowledge and experience in the interpretation of regulations, guidelines, and precedents related to drug development
• Track record for having adopted innovative regulatory strategies for novel molecular entities
• Strong strategic and analytical abilities
• Electronic submission experience
• Excellent verbal and written communication skills
• Ability to provide solid regulatory leadership to cross-functional teams and executive management
• Excellent team building, leadership, and management skills
• Excellent listening, communication, and interpersonal skills
• Demonstrated skills in managing direct reports, vendors, and others involved in Regulatory Affairs activities to meet corporate objectives
• Experience in mentoring staff to develop their skills and ensure they remain challenged professionally

Responsibilities

• Act as the EU strategic partner for regulatory teams at BridgeBio affiliates, ensuring alignment on regulatory requirements and development strategies
• Serve as the primary liaison between BridgeBio Affiliates and EMA
• Provide strategic regulatory direction for the registration and development of new products in the EU, particularly in mid-stage and late-stage development
• Depending on the filing strategy, either lead or advise on the best approach to secure regulatory approval in alignment with the commercial strategy
• Ensure that regulatory strategies support market access
• Develop and execute EU-specific regulatory strategies, including management of orphan product designations and pediatric investigational plans
• Liaise primarily with members of Clinical, CMC, Commercial, Medical Affairs, Quality, and Regulatory Affairs to develop and execute EU Regulatory strategies aligned with business objectives
• Represent Regulatory Affairs in cross-functional development teams for assigned products
• A key contributor to the strategic roadmap for the Regulatory Affairs function
• Ensure regulatory plans, in terms of standards, processes and performance, are robust through the identification and assessment of potential program risks in EU
• Lead and support scientific advice and protocol assistance meetings with EMA (European Medicines Agency)
• Actively contribute to global regulatory strategies by providing expertise in EU regulatory processes and ensuring alignment with global goals
• Maintain up-to-date working knowledge of laws, regulations, and guidelines in the EU
• Participate in the review and approval of essential documents, presentations, and report

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
• 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
• Commitment to Diversity, Equity & Inclusion