Senior Director, Global Regulatory Affairs Labeling - Remote

Overview

The Sr. Director, Global Regulatory Affairs Labeling collaborates closely with BridgeBio regulatory teams and is a subject matter expert to support the development and implementation of regulatory labeling strategies and oversight of the global labeling activities.

In Short

• Provide regulatory expertise and guidance for global labeling strategy.
• Collaborate with regulatory teams and subject matter experts.
• Lead the Label Working Group.
• Maintain awareness of global regulatory environments.
• Develop and document best-in-class labeling processes.
• Oversee maintenance and development of CCDS and local labeling deliverables.
• Review and approve change requests for labeling.
• Prepare labeling strategic plans.
• Review final artwork for production.
• Travel up to 10%.

Requirements

• Bachelor’s Degree in Pharmacy, Biology, Chemistry or related field.
• 10+ years of pharmaceutical or regulatory experience.
• Strong knowledge of US and EU product labeling requirements.
• Excellent project management skills.
• Strong communication and relationship-building abilities.
• Ability to interpret laws and regulations.

Benefits

• Patient Days to learn from individuals living with conditions.
• A culture inspired by values of patient-first and transparency.
• Access to learning and development resources.
• Market-competitive compensation and benefits package.
• Flexible PTO.
• Rapid career advancement for strong performers.