BridgeBio

3 weeks ago

Reg Affairs Assoc. 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 materials and external communications across assigned BridgeBio programs or brands. Ensure promotional activities comply with FDA regulations, OPDP guidance, and company policy by partnering with Commercial, Medical, Legal, and Clinical teams. Help shape early messaging strategy, assess regulatory risk, and support review/approval governance through the MLR committee. Monitor enforcement trends and contribute to inspection readiness and SOP refinement.

Location: San Francisco

Workplace: Hybrid

Employment Type: Full time

Job Function: Executive & General Management

Seniority: Director level

Key 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.
•Lead review and approval of promotional materials through the Medical, Legal and Regulatory (MLR) review committee.
•Partner with Regulatory Labeling to align promotional claims with approved labeling and clinical data.
•Monitor FDA enforcement actions, support OPDP inquiries, and contribute to inspection readiness and internal SOP refinement.

Pay and Benefits

Salary: USD 190,000 - 225,000 annually

Equity and Bonus:Equity

Perks:Health InsuranceDentalVision401kPaid LeaveParental LeaveCommuter BenefitsAnnual Bonus

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 relevant guidance documents.
•Experience supporting commercial launches and/or late-stage development programs.
•Demonstrated ability to influence cross-functional stakeholders in a matrixed environment.

Experience:5+ yearsPharmaceuticalRare diseaseSpecialty therapeutics

Education:PhD / Doctorate

Skills:Strategic thinkingSound judgmentInfluence without authorityRisk calibrationClear communication

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

Loading job details...

Preparing the role view and application actions.

BridgeBio

3 weeks ago

Reg Affairs Assoc. 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: San Francisco

Workplace: Hybrid

Employment Type: Full time

Job Function: Executive & General Management

Seniority: Director level

Key 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.
•Lead review and approval of promotional materials through the Medical, Legal and Regulatory (MLR) review committee.
•Partner with Regulatory Labeling to align promotional claims with approved labeling and clinical data.
•Monitor FDA enforcement actions, support OPDP inquiries, and contribute to inspection readiness and internal SOP refinement.

Pay and Benefits

Salary: USD 190,000 - 225,000 annually

Equity and Bonus:Equity

Perks:Health InsuranceDentalVision401kPaid LeaveParental LeaveCommuter BenefitsAnnual Bonus

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 relevant guidance documents.
•Experience supporting commercial launches and/or late-stage development programs.
•Demonstrated ability to influence cross-functional stakeholders in a matrixed environment.

Experience:5+ yearsPharmaceuticalRare diseaseSpecialty therapeutics

Education:PhD / Doctorate

Skills:Strategic thinkingSound judgmentInfluence without authorityRisk calibrationClear communication

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