Sobre este puesto de Manager, Finished Goods Labeling en BridgeBio Pharma
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
You will be responsible for the commercial product labeling creation and maintenance for our 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.
Responsibilities
Key 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.
Where You’ll Work
Hybrid role with in-office collaboration 2-3x per week in our San Francisco Office preferred though remote candidates may be considered.
Who You Are
- 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.
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 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
