BridgeBio Pharma
Manager, Finished Goods Labeling
San Francisco - 1800 Owens · Full-time
Sponsorship not specified$153k-$176kDetected 14 days ago
A/B TestingSupply ChainFDA RegulatoryResearchCollaborationMentoringOrganizational SkillsRegulatory Affairs
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
- Manage labeling workflows and document control activities within Perigord GLAMS label management system with Veeva RIM impacts.
- Maintain labeling version control, archival records, and audit-ready documentation.
- Support regulatory submissions involving labeling changes for U.S., EU, and additional global markets.
- Collaborate with Regulatory Affairs to ensure labeling aligns with FDA, EMA, and other global regulatory authority requirements.
- 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.
- Strong organizational skills and ability to manage multiple labeling projects simultaneously.
Requirements
- Bachelor's degree in a scientific, regulatory, or related field.
- Direct hands-on experience using Perigord GLAMS label management system (required).
- Experience coordinating labeling activities for pharmaceutical or biotechnology products.
- Working knowledge of U.S. FDA labeling regulations and familiarity with EU and international labeling requirements.
- Experience supporting labeling updates across multiple products or programs.
Compensation
- $153,000 - $176,000 USD
- Market-leading compensation
- Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
Benefits
- Employee Stock Purchase Program (ESPP)
- Pre-tax commuter benefits (transit and parking)
- Referral bonus for hired candidates
- 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) <span data-ccp-props="{"134233117":false,"134233118":fal
- Coordinate cross-functional reviews with Medical, Safety, Clinical, Quality, Legal, and Commercial teams.
- 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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