Regulatory Affairs Consultant – Global Labeling Lead
Location
United States
Posted
44 days ago
Salary
Not specified
Seniority
Senior
Bachelor Degree6 yrs expEnglish
Job Description
• Drive the labeling development and strategy, in-line with overall global strategy.
• Provide labeling expertise for Company Core Data Sheet (CCDS) and local labeling (USPI, SmPC and other).
• Evaluate and communicate strategies and anticipate risks associated with labeling content and timelines.
• Lead or contribute to cross-functional teams to align the development and maintenance of global labeling for assigned compounds.
• Partner with Global Regulatory Affairs to ensure all labeling is aligned with product global strategy.
• Support global Health Authority interaction strategy regarding all aspects of labeling.
• Collaborate with global colleagues and partners as needed.
• Develop clear communications for senior management and labeling stakeholders.
Job Requirements
- BSc or advanced scientific degree (MSc, PhD or PharmD) preferred.
- 6-8 years of relevant pharmaceutical Labeling/Regulatory experience.
- Thorough understanding of scientific principles and regulatory systems, relevant to drug development.
- Experience writing CCDS and local labeling documents for new products.
- Solid understanding and practical knowledge of labeling regulatory requirements, regulations and guidance required.
- Ability to prioritize and manage multiple high to medium complex projects simultaneously.
- Strong attention to detail.
- Preference for experience with IT systems; knowledge of Regulatory Information Management System (RIMS) and electronic document management system (EDMS); proficiency in MS Office suite.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
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