ApplySr. Director, Global Regulatory Affairs Labeling
Posted 4 months agoViewed
View full description
💎 Seniority level: Director, 10+ years
📍 Location: United States
💸 Salary: 245000.0 - 285000.0 USD per year
🔍 Industry: Biopharmaceutical
🏢 Company: BridgeBio Pharma
⏳ Experience: 10+ years
🪄 Skills: LeadershipProject ManagementCross-functional Team LeadershipGoCommunication SkillsAnalytical SkillsCollaborationProblem SolvingNegotiationAttention to detailOrganizational skillsPresentation skillsTime ManagementWritten communicationDocumentation
Requirements:
- Bachelor’s Degree in Pharmacy, Biology, Chemistry or Microbiology, or related field.
- Preferred Master’s degree and regulatory affairs certification.
- 10+ years of pharmaceutical or regulatory experience, including 8 years in a pharmaceutical environment and 3 years in a leadership role.
- Strong knowledge of US and EU product labeling requirements and regulations.
- Excellent project management and communication skills.
Responsibilities:
- Provide regulatory expertise and guidance for global regulatory labeling strategy.
- Collaborate with regulatory teams on global labeling activities.
- Lead partnerships with internal stakeholders and the Label Working Group.
- Ensure compliant management of labeling documents and assess global regulatory environments.
- Develop best-in-class labeling processes and oversee CCDS and labeling deliverables.
Apply