Manager, Finished Goods Labeling at 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.

Manager, Finished Goods Labeling

About This Role

What You’ll Do

Similar Jobs