Manager, Finished Goods Labeling
About The Position
In 2015, BridgeBio 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. They build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together they define white space, push boundaries, and empower people to solve problems. This role is responsible for the commercial product labeling creation and maintenance for their growing portfolio of products and global markets. This includes significant cross functional efforts with colleagues in CMC, Supply Chain Operations, Quality Assurance, and CMC-Regulatory Affairs, while serving as an important point of contact for labeling process issues. This role would also be the business owner of a labeling and artwork management system and occupy a visible role in the training of others and the maintenance of the given GLAMS system.
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.
- Strong organizational skills and ability to manage multiple labeling projects simultaneously.
Responsibilities
- Coordinate the creation, revision, review, and approval of product labeling including carton/container labels and artwork components.
- 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.
- Track labeling change requests and ensure timely implementation across stakeholders.
- Collaborate with Regulatory Affairs to ensure labeling aligns with FDA, EMA, and other global regulatory authority requirements.
- Coordinate cross-functional reviews with Medical, Safety, Clinical, Quality, Legal, and Commercial teams.
Benefits
- 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
- 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)
- 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
- Career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching
- Financial rewards, peer-to-peer recognition, and growth opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Manager
