What are the responsibilities and job description for the VP, Regulatory Affairs San Francisco, CA/Hybrid position at BridgeBio Pharma?

Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a Phase 3 developmental-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Our investigational product, acoramidis (AG10), is an orally administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.

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 30 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 aims 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.

The VP, Regulatory Affairs will provide strategic regulatory expertise to support the continued development and the commercialization of acoramidis for the proposed treatment of ATTR-CM and the prevention of ATTR. This role involves collaboration with cross-functional project teams in planning and execution of development strategies while providing leadership to global regulatory submissions. The VP, Regulatory Affairs will work in conjunction with various stakeholders across functional areas within the company and with external commercialization partners. The incumbent will be a key leader in the cardiorenal global regulatory team and will manage a highly skilled regulatory team based in the U.S. This role will serve as the primary point of contact for assigned regulatory agencies.

Responsibilities

Serve as a critical regulatory team member with responsibility for regulatory strategies and execution of submissions for assigned projects
Provide regulatory guidance and support for product development and registration strategies, including broad regulatory oversight for program development
Ensure high-quality and timely regulatory submissions (IND / CTA / NDA / MAA, as applicable) in compliance with all applicable regulatory requirements and alignment with corporate goals
Act as the primary liaison between the Company and assigned regulatory authorities
Direct and assist internal staff and regulatory consultants, as required, to ensure compliance of the Company’s drug development activities with all U.S. and international requirements
Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations
Great attention to detail; ability to organize, prioritize, and delegate

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

B.A. / B.S. required; M.S., Ph.D., PharmD, MD, or other related advanced scientific degree strongly preferred

Ten years minimum of relevant industry experience is generally required

Prior regulatory experience in drug development with demonstrated leadership of successful submissions to FDA (e.g., INDs, briefing packages, NDAs) and other regulatory agencies (e.g., EMA)

Prior experience leading teams responsible for marketing applications and / or license maintenance activities

Experience interacting with CROs / vendors in the management of U.S. and ex-US drug development or commercialization activities

Experience in advertising and promotional regulatory affairs activities through launch and commercialization are a plus

Knowledgeable of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry-standard practices

Proficient in written, oral, and interpersonal communications in English

Proficient user of standard M.S. Office suite (e.g., Word, PowerPoint), and experience using electronic document management systems and document review tools (e.g., Veeva)

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 de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science

A place where you own the vision – both for your program and your own career path

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)

Flexible PTO

Rapid career advancement for strong performers

Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time

Commitment to Diversity, Equity & Inclusion

Check below to see if you have what is needed for this opportunity, and if so, make an application asap.

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Remote working / work at home options are available for this role.

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VP, Regulatory Affairs San Francisco, CA/Hybrid

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