Senior Manager/Associate Director, Regulatory, 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 and Switzerland. 

To learn more about our story and company culture, visit us at https://bridgebio.com

Who You Are

The international Regulatory Lead role will support the geographical growth for our portfolio. The role will involve strategic planning and hands-on responsibilities to both define the product strategies and implementation of the regulatory strategy for the assigned products and by region. They will also manage regulatory oversight of distributors. Be an active member of the international regulatory team and represent your region’s regulatory voice in defining and shaping the commercial development plans and ensuring operational excellence.

Responsibilities

The Associate Director/Senior Manager will act as the regional lead for the company’s products, supporting regulatory activities and collaborating closely with cross-functional teams to develop and implement regional regulatory strategies. They will work with the Global Regulatory Team in the U.S. to identify and address regulatory risks in the region. As the regional regulatory representative, they will actively participate in reviewing and authoring submission content to support global filings efficiently. The role also involves advising company affiliates on regulatory strategies in the assigned regions for development programs.

• Depending on commercial strategy advise on the best approach to secure regulatory approval in alignment with business objectives.
• Support regulatory submissions across new markets, with a focus on Rest of World regions (Australia, APAC, MENA).
• Build and maintain effective relationships with distributors to streamline market access.
• Collaborate with internal teams (market access, supply chain) to align regulatory strategy with commercial objectives.
• Guide the development of region-specific strategies for orphan products.
• Serve as a link between global regulatory teams and BridgeBio affiliates and local distributors to ensure consistent regulatory compliance.
• Maintain up-to-date working knowledge of laws, regulations, and guidelines across regulatory authorities for assigned regions.
• Participate in the review and approval of essential documents, presentations, and reports.
• Occasionally, support EU-based regulatory activities as required.

The above job description documents the general nature and level of work but is not intended to be an exhaustive list of activities, duties, and responsibilities required of job incumbents. Therefore, job incumbents are expected to perform all other duties as assigned or required, as training and experience allow.  

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

• 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 6-8 years 
• Ideally a combined mix of large companies and small biotech
• Experience in regulatory affairs across Rest of World regions, particularly Australia, APAC or MENA 
• Strong interpersonal skills and ability to manage distributor relationships
• Knowledge of regulatory requirements for orphan products is highly desirable
• Ability to work in cross-functional, dynamic teams
• Strong strategic and analytical abilities 

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
• 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