BridgeBio finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh, with small satellites in other parts of the country.
To learn more, visit us at https://bridgebio.com
Who You Are
This successful candidate will report to the VP of Global Regulatory Affairs and partner with the EMEA Commercial team and the BridgeBio leadership/corporate team stakeholders. You will create and execute strategic regulatory plans to support the company’s main development asset, acoramidis (AG10), in the planned indications, including amyloid-related heart (ATTR-CM) and nervous system (ATTR-PN) disorders.
The Head of Regulatory Affairs, EMEA is the responsible lead of European Regulatory Affairs and will provide strategic direction for Eidos development programs to support product licensing. The individual will be responsible for preparing regulatory development strategies, advise executive management on regulatory risk, and lead critical interactions with European regulatory authorities on behalf of the company. They will be the responsible decision-maker for related Eidos activities in Europe and will provide support across BridgeBio affiliates as needed/agreed. The scope ranges from early clinical development through submission and maintenance of license applications.
This position involves high-level strategic planning and hands-on responsibilities to support the growing organization and pipeline. This individual is the responsible subject-matter expert for European Regulatory Affairs, leading the regulatory function accountable for filing, approval, and license maintenance in Europe.
The successful candidate is expected to develop strong relationships across departments and contribute to creating a corporate presence for Eidos and supported BridgeBio affiliates in Europe.
- Liaise primarily with members of Clinical, CMC, Commercial, Medical Affairs, Quality, and Regulatory Affairs to develop and execute European Regulatory strategies aligned with business objectives. Provide guidance, direction, and leadership on those strategies to development teams and executive management.
- Represent European Regulatory Affairs in cross-functional development teams
- Provide strategic input to planned commercial campaigns to meet business objectives while ensuring regulatory compliance
- A key contributor to the strategic roadmap for the Regulatory Affairs function
- Ensure regulatory plans, in terms of standards, processes and performance, are robust thru identification and assessment of potential program risks
- Serve as the primary liaison between Eidos and European health authorities to coordinate and prepare teams for meetings with regulatory authorities
- Scale the European Regulatory Affairs function and operational capabilities in line with anticipated company growth while identifying and collaborating with external regulatory experts and consultants as needed
- Work with appropriate partners to establish, update, and implement European Regulatory policies, standards, and procedures for the company
- Maintain up-to-date working knowledge of laws, regulations, and guidelines across European regulatory authorities.
- Participate in the review and approval of essential documents, presentations, and reports
- Develop and maintain European Regulatory budget in line with corporate priorities and goals
Education, Experience & Skills Requirements
- An advanced degree with relevant regulatory leadership experience in the biopharmaceutical industry with demonstrated capability as a successful senior regulatory leader
- 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 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
- Think independently; our goal is not merely to accept the ideas and opinions of others as fact, but instead to ask “why?” and “why not?”
- We endeavor to bring a rigorous, first-principles mindset to each problem that we take on
- Be radically transparent
- Every minute counts
- Let science speak
What We Offer
- Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to 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
- Learning and development training to help employees be the best version of themselves
- Collaborative business environment
- Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
- Excellent benefits package
- Flexible PTO
- With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
- A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
- Work with the most productive groups of R&D operators in the industry
- Partnerships with leading institutions
- A platform for meaningful scientific contributions to shine
- Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so