Reg Affairs Assoc. Director

Mavericks Wanted 

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on 
  
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.  
  
Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work. 

 

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

 

 

#LI-TB1

At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. Salary$190,000—$225,000 USD

As a global company, our comprehensive benefits may vary based on location.  We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.

For Full-Time U.S Based Roles:

Financial & Rewards  

• Market-leading compensation   

• 401(k) with employer match   

• Employee Stock Purchase Program (ESPP)  

• Pre-tax commuter benefits (transit and parking)  

• Referral bonus for hired candidates  

• Subsidized lunch and parking on in-office days  

Health & Well-Being  

• 100% employer-paid medical, dental, and vision premiums for you and your dependents  

• Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)  

• Fertility & family-forming benefits  

•  Expanded mental health support (therapy and coaching resources)  

• Hybrid work model with flexibility  

• Flexible, “take-what-you-need” paid time off and company-paid holidays  

• Comprehensive paid medical and parental leave to care for yourself and your family  

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, & BetterUp Coaching 

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