Reg Affairs Assoc. Director

BridgeBio Pharma

8d•$190,000 - $225,000•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

Experience in rare disease or specialty therapeutics.
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

Responsibilities

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.
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.
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.
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.

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
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
Career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
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
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)
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
Career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching