Sr. Director, Regulatory Affairs International

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

You will report to the Head of International Regulatory Affairs and work closely with the US-based teams and the EMEA commercial organization to lead, specifically the Head of Commercial, to assess the capabilities of the identified distributors and business partners' regulatory. You will be accountable for implementing the regulatory, quality and safety activities to support global commercial expansion and ongoing development. You will create and implement the operational strategy and advise the BridgeBio Affiliate companies for the current and future programs within the assigned region. You will serve as a regional regulatory representative, actively involved in reviewing and authoring regulatory submission content to support international submissions as efficiently as possible. This role is a hybrid position.

This position will involve high-level strategic planning and hands-on responsibilities to define the product strategies and their implementation. You will lead key product projects for the region and establish the regulatory business processes to secure an initial license, Life Cycle Management and maintenance for the assigned markets and initially focus on supporting commercial partners and distributors. This will include coordinating regulatory impact assessment for CMC and Safety Changes and ensuring effective communication to maintain product supply.

• You will collaborate with the Regional and product Regulatory Lead (within the affiliates based in the US) to identify and propose mitigations for the regulatory risks for the region and serve as a regional regulatory representative, with active involvement in the review and authoring of regulatory submission content to support the worldwide submissions as efficiently as possible.
• Provide regional regulatory affairs product strategy to ensure the affiliates have access to regional-specific requirements and insight to enable initiation of clinical trials and securing relevant regulatory designations for orphan products.
• Provide advice and insight to ensure regulatory strategies support market access, including Early Access opportunities.
• Liaise, negotiate and represent BBIO with Regulatory Authorities' interactions in collaboration with partner regulatory teams.
• Support licensing, maintenance, and regulatory strategy implementation, with oversight of operational delivery by Pharmalex in a timely and compliant manner.
• Decision maker for country-related requirements (i.e. OOS notification, Local PQC review and escalation)
• Liaise primarily with Clinical, CMC, Commercial, Medical Affairs, Quality, and Regulatory Affairs members to develop and execute Regulatory strategies aligned with business objectives and provide relevant insights for the assigned region.
• Onboarding of distributors in accordance with the commercial plan in designated regions.
• Ensuring operational interface with the Pharmalex operating model provides regulatory support across multiple markets and regions.
• Initial applications submitted via distributors or independently are transferred and maintained effectively and aligned with any relevant changes impacting regulatory documentation.
• Managing internal interface on behalf of the distributor to supply chain for amendments to label and product approval in a timely manner for the assigned distributor (s) by region.
• Provide strategic input to planned commercial campaigns to meet business objectives while ensuring regulatory compliance accountable for MLR at regional and national levels, escalating required concerns from in-country PLX staff with legal accountability, as appropriate.
• Liaise, negotiate and represent BBIO with Regulatory Authorities in assigned region interactions.
• Support licensing, maintenance, and regulatory strategy implementation, with oversight of operational delivery by Pharmalex in a timely and compliant manner.
• Decision maker for country-related requirements (i.e. OOS notification, Local PQC review and escalation)

• 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 working in one or more areas of regulatory affairs in the pharmaceutical industry or experience with a health authority for 10-15 years.
• Ideally, a combined mix of large companies 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 interpreting regulations, guidelines, and precedents related to drug development.
• Track record for having adopted innovative regulatory strategies for novel molecular entities.
• Experience working in a highly outsourced operating model and managing deliverables across a complex organisation.
• 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.
• Experience 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, health, welfare & retirement programs
• Commitment to Diversity, Equity & Inclusion

BridgeBio Pharma, Inc., along with its affiliates and subsidiaries worldwide (collectively, “BridgeBio,” “we,” “us,” or “our”), is committed to handling personal data responsibly and in accordance with applicable law. The BridgeBio Candidate Privacy Notice (“Notice”) explains our data collection and processing practices in the context of our employment opportunities in the European Economic Area, Switzerland, and the United Kingdom. It also describes your data protection rights, including a right to object to some of the processing that we carry out. More information about your rights, and how to exercise them in this context, is set out here.