BridgeBio

3 weeks ago

Reg Affairs Director

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 8 hours agoStatus: Live

Job Summary

Provide strategic regulatory leadership for promotional advertising and external communications across assigned BridgeBio programs or brands. Own regulatory compliance for promotional materials under FDA and OPDP guidance, shape messaging strategy early, and assess promotional risks and opportunities. Lead and govern review/approval through the Medical, Legal and Regulatory committee, align claims with labeling and data, and support enforcement and inspection readiness while partnering with cross-functional stakeholders.

Location: United States

Workplace: Remote

Employment Type: Full time

Job Function: Executive & General Management

Seniority: Director level

Key Responsibilities

•Serve as the Ad Promo regulatory lead for assigned commercial and/or pipeline products, providing 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 and interpret/apply FDA promotional requirements and OPDP guidance.
•Lead review and approval of promotional materials through the Medical, Legal and Regulatory (MLR) review committee, ensuring accuracy, balance, and substantial evidence.
•Provide strategic direction on disease awareness, HCP and patient materials, digital content, and launch campaigns, and support advisory boards, speaker programs, and field training materials as needed.
•Monitor FDA enforcement actions and emerging trends, support OPDP inquiries and regulatory questions, and contribute to inspection readiness for promotional review processes.

Pay and Benefits

Salary: USD 230,000 - 285,000 annually

Equity and Bonus:Equity

Perks:Health InsuranceDentalVision401kEquityHsaFsaPaid LeaveParental LeaveAnnual BonusFlexible Work

Key Requirements

•Advanced scientific degree (PharmD, PhD, MD) or equivalent.
•8+ years of pharmaceutical experience with 5+ years of relevant ad promo experience.
•Deep understanding of FDA promotional regulations, OPDP expectations, and applicable guidance documents.
•Experience supporting commercial launches and/or late-stage development programs.
•Demonstrated ability to influence cross-functional stakeholders in a matrixed environment.

Experience:8+ yearsPharmaceuticalBiopharma

Skills:Strategic thinkingSound judgmentInfluence without authorityRisk calibrationClear communication

Languages:English

Tech Stack:AI

Company Brief

BridgeBio

Develops medicines for patients with genetic diseases by advancing targeted therapeutics from discovery through clinical development and commercialization, focusing on genetically defined diseases with high unmet medical need.

Industry: Biotech

Company Size: Large (251 to 1,000 employees)

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Palo Alto, United States

Founded: 2015

Website LinkedIn

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BridgeBio

3 weeks ago

Reg Affairs Director

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 8 hours agoStatus: Live

Job Summary

Location: United States

Workplace: Remote

Employment Type: Full time

Job Function: Executive & General Management

Seniority: Director level

Key Responsibilities

•Serve as the Ad Promo regulatory lead for assigned commercial and/or pipeline products, providing 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 and interpret/apply FDA promotional requirements and OPDP guidance.
•Lead review and approval of promotional materials through the Medical, Legal and Regulatory (MLR) review committee, ensuring accuracy, balance, and substantial evidence.
•Provide strategic direction on disease awareness, HCP and patient materials, digital content, and launch campaigns, and support advisory boards, speaker programs, and field training materials as needed.
•Monitor FDA enforcement actions and emerging trends, support OPDP inquiries and regulatory questions, and contribute to inspection readiness for promotional review processes.

Pay and Benefits

Salary: USD 230,000 - 285,000 annually

Equity and Bonus:Equity

Perks:Health InsuranceDentalVision401kEquityHsaFsaPaid LeaveParental LeaveAnnual BonusFlexible Work

Key Requirements

•Advanced scientific degree (PharmD, PhD, MD) or equivalent.
•8+ years of pharmaceutical experience with 5+ years of relevant ad promo experience.
•Deep understanding of FDA promotional regulations, OPDP expectations, and applicable guidance documents.
•Experience supporting commercial launches and/or late-stage development programs.
•Demonstrated ability to influence cross-functional stakeholders in a matrixed environment.

Experience:8+ yearsPharmaceuticalBiopharma

Skills:Strategic thinkingSound judgmentInfluence without authorityRisk calibrationClear communication

Languages:English

Tech Stack:AI

Company Brief

BridgeBio

Industry: Biotech

Company Size: Large (251 to 1,000 employees)

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Palo Alto, United States

Founded: 2015

Website LinkedIn