23 hours ago

Senior Manager/Associate Director, Regulatory Sciences

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 10 hours agoStatus: Live

Job Summary

Lead CMC Regulatory Sciences work across the product lifecycle for small-molecule programs, partnering with Drug Substance, Drug Product, Analytical Development, and Regulatory Affairs teams. Author and review drug substance/product regulatory sections for IND/IMPD/CTA and NDA/MAA/JNDA submissions and post-approval changes, respond to health authority queries, and maintain quality risk assessments aligned to ICH guidelines while improving submission efficiency with AI-enabled tools.

Location: San Francisco

Workplace: Hybrid

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Director level

Key Responsibilities

•Collaborate with small molecule CMC technical teams to design and implement drug substance and drug product control strategies across the program life cycle.
•Author and review drug substance and drug product sections for clinical trial applications/supplements (IND, IMPD, CTA) and marketing authorization applications and post-approval changes/variations (NDA, MAA, JNDA) with stakeholders.
•Author responses to health authority queries and information requests related to Quality sections of clinical and marketing approval applications.
•Prepare and maintain quality risk assessments for mutagenic impurities (ICH M7), elemental impurities (ICH Q3D), and nitrosamines per global regulatory guidance.
•Apply AI-enabled tools and digital technologies to improve regulatory submission efficiency, quality, and consistency while following company policies and data governance standards.

Pay and Benefits

Salary: USD 188,000 - 215,000 annually

Equity and Bonus:Equity

Perks:401kHealth InsuranceDentalVisionHsaFsaPaid LeaveParental LeaveMeal Allowance

Key Requirements

•PhD with 7+ years relevant experience, or BS/MS with 10+ years relevant experience.
•Combination of CMC development and regulatory authoring experience is preferred; background in drug product or analytical development is a plus.
•Familiarity with FDA, EMA, and ICH guidelines for INDs/NDAs/MAAs, plus thorough understanding of cGMP, quality, and regulatory requirements for drug substance and drug product manufacturing.
•Working knowledge of analytical method development, validation, and global stability requirements.
•Ability to develop strategies and advise technical teams in ambiguous regulatory landscapes, with strong communication, organization, and time-management skills.

Experience:7+ yearsBiotechBiopharmaceuticalsCMC developmentRegulatory authoringSmall molecules

Education:PhD / Doctorate

Skills:Attention to detailTime managementOral communicationWritten communicationOrganizational skills

Languages:English

Tech Stack:AIDigital technologies

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

23 hours ago

Senior Manager/Associate Director, Regulatory Sciences

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 10 hours agoStatus: Live

Job Summary

Location: San Francisco

Workplace: Hybrid

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Director level

Key Responsibilities

•Collaborate with small molecule CMC technical teams to design and implement drug substance and drug product control strategies across the program life cycle.
•Author and review drug substance and drug product sections for clinical trial applications/supplements (IND, IMPD, CTA) and marketing authorization applications and post-approval changes/variations (NDA, MAA, JNDA) with stakeholders.
•Author responses to health authority queries and information requests related to Quality sections of clinical and marketing approval applications.
•Prepare and maintain quality risk assessments for mutagenic impurities (ICH M7), elemental impurities (ICH Q3D), and nitrosamines per global regulatory guidance.
•Apply AI-enabled tools and digital technologies to improve regulatory submission efficiency, quality, and consistency while following company policies and data governance standards.

Pay and Benefits

Salary: USD 188,000 - 215,000 annually

Equity and Bonus:Equity

Perks:401kHealth InsuranceDentalVisionHsaFsaPaid LeaveParental LeaveMeal Allowance

Key Requirements

•PhD with 7+ years relevant experience, or BS/MS with 10+ years relevant experience.
•Combination of CMC development and regulatory authoring experience is preferred; background in drug product or analytical development is a plus.
•Familiarity with FDA, EMA, and ICH guidelines for INDs/NDAs/MAAs, plus thorough understanding of cGMP, quality, and regulatory requirements for drug substance and drug product manufacturing.
•Working knowledge of analytical method development, validation, and global stability requirements.
•Ability to develop strategies and advise technical teams in ambiguous regulatory landscapes, with strong communication, organization, and time-management skills.

Experience:7+ yearsBiotechBiopharmaceuticalsCMC developmentRegulatory authoringSmall molecules

Education:PhD / Doctorate

Skills:Attention to detailTime managementOral communicationWritten communicationOrganizational skills

Languages:English

Tech Stack:AIDigital technologies

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