Senior Director, Regulatory Strategy, EU
Vor 3 Tagen
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
The role will involve high level strategic planning and hands-on responsibilities to both define the product strategies and implementation of the regulatory strategy for the assigned products in the EU. The product portfolio will be adjusted based on demand to ensure a balanced workload. They will actively identify the regulatory strategy for EU and manage regulatory oversight of any vendors involved in the support of the products.
ResponsibilitiesThe Senior Director will be the EU lead for the company's products. They will work with the relevant Global Regulatory Leads based in the US to identify and propose mitigations for the regulatory risks for the region. They will serve as regional regulatory representative, with active involvement in the review and authoring of regulatory submission content to support the EU submissions as efficiently as possible. The role will also be responsible for advising the BridgeBio Affiliates (Discovery and Clinical Development companies) on regulatory strategy in early development across the portfolio, focused on ensuring utilization of early patient access.
- 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
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
- 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
- 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)
- Commitment to Diversity, Equity & Inclusion
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