
Printed Labeling Components Specialist
17 hours ago
We are seeking an experienced professional to join our Global Regulatory Affairs team as a Global Labeling Operations Lead.
ResponsibilitiesAs a key member of our team, you will be responsible for managing labeling artwork projects across multiple products, coordinating lifecycle management of labeling artwork, and providing expertise to cross-functional teams and external vendors regarding regulatory requirements.
Key Qualifications:
- At least 5 years of experience in Labeling Operations within the pharmaceutical industry.
- Experience developing regulatory content for printed labeling components (e.g., carton and container) for EU (MAA/variations) and/or US (NDA/BLA) submissions.
- Strong leadership skills and ability to collaborate effectively in cross-functional teams.
Additional Requirements:
- Fluency in English, additional language skills are beneficial.
- Strong attention to detail and excellent communication and negotiation skills.
Personal Attributes:
- Results-driven and team-oriented attitude.
- Excellent organizational and time management skills.
- Hands-on approach and flexibility to succeed in a small-team environment.
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