BridgeBio Pharma
Senior Manager/Associate Director, Regulatory Sciences
San Francisco - 1800 Owens · Director · Full-time
Sponsorship not specified$188k-$215kDetected 1 day ago
Machine LearningA/B TestingProduct ManagementSupply ChainGMPFDA RegulatoryResearchCommunicationCollaborationTime ManagementOrganizational SkillsRegulatory Affairs
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odds of building a lasting career here
47Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role35
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
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About the role
- Mavericks Wanted When was the last time you achieved the impossible?
- Together we define white space, push boundaries, and empower people to solve problems.
- Together, we'll ask "why not?" and help reengineer the future of biopharma.
Responsibilities
- 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.
- 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.
- 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.
- 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 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.
- Ability to interpret regulatory requirements and collaborate with development and/or commercial teams to create actionable plans to meet these requirements.
Requirements
- PhD with 7+ years relevant experience, or BS/MS with 10+ years relevant experience.
- Familiarity with FDA, EMA, and ICH guidelines for INDs/NDAs/MAAs.
- Working knowledge of analytical method development, validation, and global stability requirements.
- Ability to work independently as well as in a team.
Nice to have
- Combination of experience in CMC development and regulatory authoring is preferred.
- Background in drug product or analytical development is a plus.
Compensation
- $188,000 - $215,000 USD
- Market-leading compensation
Benefits
- Author responses to health authority queries and information requests related to Quality sections of clinical and marketing approval applications.
- Employee Stock Purchase Program (ESPP)
- Pre-tax commuter benefits (transit and parking)
- Referral bonus for hired candidates
- Health & Well-Being
- 100% employer-paid medical, dental, and vision premiums for you and your dependents
- As a global company, our comprehensive benefits may vary based on location.
Company info
- At BridgeBio, we value curiosity and experimentation-including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.
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