What You'll Do #LI-RV1

The Associate Director/Director, Regulatory Advertising & Promotion is responsible for providing strategic regulatory leadership for promotional materials and external communications across assigned programs or brands. This role ensures that all promotional activities are compliant with FDA regulations, industry guidance, and company policy, while enabling the business to communicate effectively and competitively.

In addition to timely review of materials, the Associate Director/Director is expected to help shape messaging strategy early, anticipate regulatory risk and opportunities, and influence cross-functional partners to drive compliant, compelling communications that enable the business to deliver content and messaging effectively to its stakeholders.

Responsibilities

Strategic Regulatory Leadership

• Serve as the Ad Promo regulatory lead for assigned products (commercial and/or pipeline).

• Provide proactive guidance on promotional strategy, claims development, and risk positioning.

• Partner with Commercial, Medical, Legal, and Clinical teams to align messaging with labeling and data.

• Interpret and apply FDA regulations, OPDP guidance, enforcement trends, and industry standards to business initiatives.

• Assess regulatory risk and recommend clear, practical mitigation strategies.

Promotional Review & Governance

• Lead review and approval of promotional materials through the Medical, Legal and Regulatory review committee (MLR).

• Ensure materials are accurate, balanced, and supported by substantial evidence.

• Provide strategic direction on disease awareness, HCP and patient materials, digital content, and launch campaigns.

• Support advisory boards, speaker programs, and field training materials as needed.

• Contribute to development and refinement of internal SOPs and review processes.

Labeling & Claims Strategy

• Partner with Regulatory Labeling to ensure promotional claims align with approved labeling and clinical data.

• Anticipate labeling implications for promotional planning, especially during launch readiness.

• Support development of core claims documents and messaging frameworks.

Inspection & Enforcement Readiness

• Monitor FDA enforcement actions and emerging trends.

• Support responses to OPDP inquiries or regulatory questions related to promotional materials.

• Contribute to inspection readiness activities related to promotional review processes.

Where You'll Work

This role requires onsite presence at our San Francisco office.

Who You Are

Required

• Advanced scientific degree (PharmD, PhD, MD) or equivalent.

• 8+ years of pharmaceutical experience with 5+ years plus relevant ad promo experience

• Deep understanding of FDA promotional regulations, OPDP expectations, and relevant guidance documents.

• Experience supporting commercial launches and/or late-stage development programs.

• Demonstrated ability to influence cross-functional stakeholders in a matrixed environment.

Preferred

• Experience in rare disease or specialty therapeutics.

Competencies

• Strategic thinker: Balances compliance with business enablement.

• Sound judgment: Makes clear, defensible decisions under ambiguity.

• Influence without authority: Navigates cross-functional dynamics effectively.

• Risk calibration: Knows when to hold firm and when to flex.

• Clear communicator: Delivers direct, actionable guidance.

• You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies

Impact

This role directly shapes how the organization communicates its science and value to healthcare professionals and patients. The Associate Director/Director is a critical safeguard for regulatory compliance and a strategic partner to the business during growth and launch phases.

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

Financial Benefits:

• Market leading compensation 

• 401K with 100% employer match on first 3% & 50% on the next 2%

• Employee stock purchase program

• Pre-tax commuter benefits

• Referral program with $2,500 award for hired referrals

Health & Wellbeing:

• Comprehensive health care with 100% premiums covered - no cost to you and dependents

• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)

• Hybrid work model - employees have the autonomy in where and how they do their work 

• Unlimited flexible paid time off - take the time that you need

• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents

• Flex spending accounts & company-provided group term life & disability 

• Subsidized lunch via Forkable on days worked from our office

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility

• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching

• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

Position Overview

BridgeBio is seeking a reliable and highly organized Office Assistant to support the day-to-day operations for the Office of the Chief Regulatory Officer (OCRO), in our Washington, DC office. This role is fully in-office and is responsible for maintaining an efficient, professional, and welcoming workplace environment at BridgeBio’s DC site. The ideal candidate is proactive, detail-oriented, and comfortable providing light administrative support to BridgeBio leadership and staff as needed.

Key Responsibilities

• Serve as the primary on-site point of contact for BridgeBio Washington, DC office operations and facilities needs.
• Coordinate office logistics, including mail distribution, shipping/receiving, and supply inventory management for the BridgeBio DC office.
• Order and maintain office supplies, kitchen supplies, and other necessary materials for BridgeBio staff.
• Ensure common areas, conference rooms, and workspaces are organized and presentable to BridgeBio standards.
• Support meeting logistics, including scheduling BridgeBio conference rooms, setting up meeting spaces, and coordinating catering when needed.
• Liaise with building management, landlord, vendors, and service providers for maintenance or operational needs on behalf of BridgeBio.
• Assist with onboarding logistics for new BridgeBio OCRO hires (workspace setup, badge coordination, BridgeBio IT/security account coordination, office orientation).
• Provide executive/administrative support to BridgeBio OCRO leadership such as calendar coordination, document preparation, expense submission, and travel booking assistance.
• Help plan and coordinate small BridgeBio office events or team gatherings.
• Maintain BridgeBio DC office documentation, procedures, and vendor/contact lists.
• Perform other administrative and operational duties as assigned to support BridgeBio’s Washington, DC operations.

Qualifications

• 5+ years of experience in office management, administrative, or office assistant role.
• Strong organizational skills with the ability to manage multiple tasks simultaneously.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint) and/or Google Workspace.
• Professional demeanor with strong interpersonal skills.
• Ability to work independently in a fully in-office environment.
• High level of discretion and ability to handle sensitive information.
• Flexible and adaptable in a dynamic work environment.

Preferred Qualifications

• Experience supporting senior leadership.
• Prior experience in a corporate, biotech, or professional services environment.
• Experience coordinating vendors or managing small office budgets.
• Ability to learn and develop proficiency in using a wide range of office technologies including business applications, software, printers, and computer hardware and accessories.
• Comfortable troubleshooting common office technology issues in support of printing, desktop displays, computer accessories, etc.
• Experience managing complex executive calendars and shared mailboxes
• Experience in website content administration via Microsoft SharePoint
• Familiarity with procurement and expense management systems, E.G. Coup and SAP Concur

Work Environment & Schedule

• This position is based in BridgeBio’s Washington, DC office and requires full-time, in-office presence during standard business hours. This is a temporary/contract role with an anticipated duration to be determined based on BridgeBio’s business needs.

What You'll Do 

The Vice President, Regulatory Affairs will oversee BridgeBio’s Operations and Labeling  functions, and will also support regulatory strategy as needed. This leader will manage a team of subject matter experts and leaders responsible for Regulatory Operations, Regulatory Business Operations, and Labeling, ensuring excellence, compliance, and strategic alignment across all regulatory activities.

The VP will ensure the organization has the right infrastructure, technology, and governance to support global submissions, and compliant labeling, while integrating advanced capabilities such as artificial intelligence to drive efficiency and insight.

The ideal candidate brings previous broad global regulatory expertise spanning for both development and commercial products, labeling, and operations, combined with understanding and experience in regulatory affairs, and the ability to lead in a fast-paced, entrepreneurial environment. #LI-TC1

Responsibilities

Strategic & Functional Leadership

• Provide overarching leadership and strategic direction for the Regulatory Operations, Regulatory Business Operations, and Labeling, each led by experienced subject matter experts and team leaders

• Partner with the Chief Regulatory Officer and Regulatory Leaders to ensure alignment of operational strategy with regulatory goals

• Foster an infrastructure that enables  innovation, speed, and accountability within and across the regulatory organization

• Lead the integration of artificial intelligence and advanced digital tools across systems and processes to enhance productivity, compliance, and decision-making

• Establish and maintain the framework for regulatory SOPs, work instructions, and desk procedures to ensure consistency, compliance, and clarity

• Lead and develop a team of team leaders and subject matter experts, fostering a collaborative and high-performance culture

• Ensure effective resource planning, talent development, and staff augmentation as needed to support corporate priorities

• Promote continuous learning and professional development within the broader regulatory organization

Where You'll Work

This is a hybrid role based either in San Francisco, or Washington, D.C. Remote will also be considered.

Who You Are

• Advanced degree in a scientific discipline (PharmD, PhD, MD, or MS) required.

• 15+ years of progressive regulatory experience in the biopharmaceutical industry, including leadership of multidisciplinary regulatory teams.

• Proven experience in labeling strategy and operations for development and commercial products, with deep understanding of global submission requirements and post-approval obligations.

• Demonstrated expertise in establishing and managing regulatory systems (e.g., Veeva Vault, RIM) and process governance frameworks (SOPs, WIs, desk procedures).

• Strong working knowledge of clinical and nonclinical regulatory strategy and interactions with global health authorities.

• Track record of leading or enabling digital transformation or AI integration within regulatory or adjacent functions.

• Exceptional leadership, communication, and influencing skills, with the ability to operate effectively in a matrixed, fast-paced environment.

• You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies.

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

Financial Benefits:

• Market leading compensation 

• 401K with 100% employer match on first 3% & 50% on the next 2%

• Employee stock purchase program

• Pre-tax commuter benefits

• Referral program with $2,500 award for hired referrals

Health & Wellbeing:

• Comprehensive health care with 100% premiums covered - no cost to you and dependents

• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)

• Hybrid work model - employees have the autonomy in where and how they do their work 

• Unlimited flexible paid time off - take the time that you need

• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents

• Flex spending accounts & company-provided group term life & disability 

• Subsidized lunch via Forkable on days worked from our office

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility

• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching

• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities