---
title: 'Sr. Manager/Associate Director, CMC Regulatory Sciences at BridgeBio Pharma'
canonical: 'https://feeny.ai/job/sr-manager-associate-director-cmc-regulatory-sciences-bridgebio-pharma-san-86s4pszygt07'
type: 'job'
last_seen: '2026-09-09'
---

# Sr. Manager/Associate Director, CMC Regulatory Sciences at BridgeBio Pharma

- **Company:** BridgeBio Pharma
- **Location:** San Francisco, CA
- **Compensation:** $188k–$215k
- **Posted:** 2026-07-30
- **Last confirmed live:** 2026-09-09
- **Apply:** https://job-boards.greenhouse.io/bridgebio/jobs/5197212007

## Job description

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

Senior Manager / Associate Director, CMC Regulatory Sciences reports to the head of CMC Regulatory Sciences and will support BridgeBio Pharma and its subsidiaries, including Eidos Therapeutics, Calcilytix Therapeutics, and ML Bio Solutions. This position will work with CMC technical teams (Drug Substance, Drug Product, and Analytical Development) and Regulatory Affairs to design and implement control strategies in alignment with ICH and regional regulatory requirements throughout the product lifecycle. This position will be responsible for authoring and reviewing drug substance and drug product sections of global clinical trial applications and supplements, marketing authorization applications, and post-approval changes, as well as responding to health agency queries and information requests.

## Responsibilities

- Collaborate with small molecule CMC technical teams to design and implement drug substance and drug product control strategies to meet current and evolving regulatory requirements throughout a program’s life cycle.
- Author and review technically complex drug substance and drug product sections of clinical trial applications and supplements (e.g., IND, IMPD, CTA), and marketing authorization applications and post-approval changes/variations (e.g., NDA, MAA, JNDA) in collaboration with subject matter experts and 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, including but not limited to, identification and control of (potentially) mutagenic impurities in accordance with ICH M7, elemental impurities in accordance with ICH Q3D, and nitrosamines in accordance with global regulatory guidelines.
- Advise development teams on the selection and justification of regulatory starting materials, establishment of specifications, and characterization of manufacturing processes.
- Identify key regulatory issues with potential impact across multiple projects. Raise awareness with and appropriately influence affected teams.
- Apply AI-enabled tools and digital technologies to improve the efficiency, quality, and consistency of regulatory submissions while adhering to company policies and data governance standards
- Interface with International Regulatory Affairs, CMC Regulatory Affairs, Supply Chain Management, and CMC technical teams on global launch sequence, filing strategies, and regional filing requirements which may impact CMC manufacturing timelines, stability, and/or control strategies.

Where You'll Work

This is a hybrid role and preference will be given to candidates local to San Francisco and able to work in-office 2–3x per week. A US-based fully remote role may be considered for the right candidate.

## Who You Are

- PhD with 7+ years relevant experience, or BS/MS with 10+ years relevant experience.
- Combination of experience in CMC development and regulatory authoring is preferred.  Background in drug product or analytical development is a plus.
- Familiarity with FDA, EMA, and ICH guidelines for INDs/NDAs/MAAs. Thorough understanding of cGMP, quality and regulatory requirements for drug substance and drug product manufacturing. Ability to interpret regulatory requirements and collaborate with development and/or commercial teams to create actionable plans to meet these requirements.
- Working knowledge of analytical method development, validation, and global stability requirements.
- Ability to develop strategies, make decisions, and advise technical teams in ambiguous regulatory landscapes.
- Strong attention to detail and time management skills. Excellent oral and written communication skills. Excellent organizational skills and demonstrated ability to deliver on multiple projects simultaneously with tight timelines.
- Ability to effectively interface with and/or manage highly skilled internal staff.  Ability to work independently as well as in a team. Ability to build good working relationships.

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 $188,000—$215,000 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 BridgeBio 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

## About BridgeBio Pharma

## Company Overview
- **One-liner**: BridgeBio Pharma develops transformative medicines for genetic conditions, using a decentralized hub-and-spoke model to accelerate drug development from early research to commercialization.
- **Entity Type**: Public (Nasdaq: BBIO)
- **Headquarters**: Palo Alto, California, USA (with hybrid offices in San Francisco, CA)
- **Founded**: Not explicitly stated in provided sources; the company references “over the past 10 years” as of 2026, suggesting founding around 2015–2016.
- **Founders**: Not publicly available from provided sources.

## Core Business
- **Primary industry**: Biotechnology / Genetic disease therapeutics
- **Target customers**: Patients living with genetic conditions, healthcare providers, payers, and academic research partners
- **Mission**: “To develop transformative medicines for genetic conditions” and “bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations.”

## Products & Services
BridgeBio’s pipeline includes both approved therapies and investigational candidates across dozens of indications. Key offerings:

- **Acoramidis**: Approved for transthyretin amyloidosis (ATTR) – a first-in-class treatment with $8B+ peak year sales potential.
- **Infigratinib**: Phase 3 completed for achondroplasia; published in the *New England Journal of Medicine* (2026).
- **BBP-418**: Investigational for Limb-Girdle Muscular Dystrophy Type 2I/R9 (LGMD2I/R9).
- **Encaleret**: Investigational for Autosomal Dominant Hypocalcemia Type 1 (ADH1).
- **BBP-812**: Investigational for Canavan Disease.
- **BridgeBio Oncology Therapeutics (BBOT)**: Subsidiary focused on RAS and PI3Kα-driven cancers.
- **GondolaBio**: Subsidiary developing bioavailable small molecule inhibitors for oncology.
- **Other programs**: Covering hypochondroplasia, chronic hypoparathyroidism, and more.

The company has received **3 FDA approvals** and has over **70+ peer-reviewed publications**.

## Market Standing
- **Valuation / Market Cap**: Not explicitly stated in provided data; as a public company, current market cap can be found on financial platforms (e.g., ~$8B based on peak sales potential, but not a direct valuation number).
- **Key Metric**: **3 FDA-approved medicines**; **2000+ patients enrolled** in global clinical trials; **6 Phase 3 trials** conducted over the past 10 years.
- **Notable Investors / Partners**: Not detailed in provided sources, but the company partners with leading academic institutions to advance early-stage research.
- **Growth Signals**: Recent publication of Phase 3 PROPEL 3 trial results in NEJM (June 2026); expansion into oncology via BBOT and GondolaBio; 100% of pipeline is first-in-class or best-in-class; 48 unique disease indications targeted.

## Competitive Advantages
- **Hub-and-spoke model**: Decentralized structure where autonomous affiliate teams (spokes) focus on specific conditions, while a central hub provides clinical, regulatory, and commercial expertise. This enables speed, scalability, and risk reduction.
- **First-in-class / best-in-class focus**: 100% of pipeline aims to be first or best in class, targeting underserved genetic conditions with clear biological rationale.
- **Speed and adaptability**: The model allows rapid pivoting to the most promising opportunities, reducing development timelines compared to traditional biotech.
- **Strong scientific foundation**: Over 70 peer-reviewed papers and collaborations with top academic institutions.

## Strategic Focus
- **Advance late-stage pipeline**: Prioritize Phase 3 programs (e.g., infigratinib for achondroplasia, acoramidis for ATTR) and seek additional FDA approvals.
- **Expand into oncology**: Leverage subsidiaries BBOT and GondolaBio to address RAS/PI3Kα-driven cancers.
- **Maintain urgency**: “Every minute counts” – continue to operate with speed and autonomy to bring treatments to patients faster.
- **Build on commercial success**: Leverage existing approved products to fund further R&D and expand global reach.

## Why Work Here
- **Award-winning culture**: Named **#1 Best Place to Work** by BioSpace (2026, small biotech category) with an **88% employee engagement score** in 2025.
- **Flexible work model**: Hybrid policy with offices in San Francisco and Palo Alto, CA; “flexible working model” emphasized.
- **Compensation and benefits**: Market-leading pay, comprehensive healthcare, and strong emphasis on growth and internal mobility.
- **Impact-driven mission**: Work on transformative treatments for genetic conditions where patient need is urgent – “Impatient for Patients” is a core mantra.
- **Values**: Put patients first, let science speak, think independently, speak up, and act with urgency. The culture is described as “high on standards, low on convention.”
- **Growth opportunities**: 113 open jobs (as of mid-2026) across functions including clinical, regulatory, manufacturing, commercial, and corporate; talent community available for future roles.

## Sources
1. [bridgebio.com](https://bridgebio.com/) – Home page with pipeline overview and $8B peak sales potential
2. [bridgebio.com/about](https://bridgebio.com/about) – Company description, hub-and-spoke model, and key metrics
3. [bridgebio.com/careers](https://bridgebio.com/careers) – Careers page with awards, culture, and benefits
4. [investor.bridgebio.com](https://investor.bridgebio.com/overview/default.aspx) – Investor relations overview, latest news, and corporate presentation
5. [job-boards.greenhouse.io/bridgebio](http://job-boards.greenhouse.io/bridgebio) – Current job listings (113 roles) and departmental categories

## Other roles at BridgeBio Pharma

- [Medical Director, Clinical Science](https://feeny.ai/job/medical-director-clinical-science-bridgebio-pharma-united-states-bnevf5whdv71) — United States
- [Director, Patient Advocacy, International](https://feeny.ai/job/director-patient-advocacy-international-bridgebio-pharma-switzerland-4rh4brw9vy3v) — Switzerland
- [Head of International Communications](https://feeny.ai/job/head-of-international-communications-bridgebio-pharma-switzerland-rfdfezqqhfsj) — Switzerland
- [Manager/Sr. Manager, Analytical Development](https://feeny.ai/job/manager-sr-manager-analytical-development-bridgebio-pharma-san-francisco-c5ksttf7swbg) — San Francisco, CA
- [Senior Director, Clinical Pharmacology](https://feeny.ai/job/senior-director-clinical-pharmacology-bridgebio-pharma-san-francisco-a58xn2xz5z43) — San Francisco, CA
- [Senior MSL/MSL - NJ/NY](https://feeny.ai/job/senior-msl-msl-nj-ny-bridgebio-pharma-united-states-tc9bh5vtcje3) — United States
- [Sr. MSL/MSL - New England](https://feeny.ai/job/sr-msl-msl-new-england-bridgebio-pharma-united-states-5p37bf97vvfc) — United States
- [Therapeutic Sales Specialist - Richmond, Norfolk and Eastern NC](https://feeny.ai/job/therapeutic-sales-specialist-richmond-norfolk-and-eastern-nc-bridgebio-pharma-4kez34hbdjt0) — United States
- [Senior MSL/MSL - Gulf](https://feeny.ai/job/senior-msl-msl-gulf-bridgebio-pharma-united-states-5p1rh3d2cgsz) — United States
- [Area Business Manager - Atrruby (West)](https://feeny.ai/job/area-business-manager-atrruby-west-bridgebio-pharma-united-states-eztne6a65g84) — United States