
Regulatory Labeling Coordinator Leader
11 hours ago
As a key member of Sobi's Global Regulatory Affairs team, you will play a vital role in ensuring compliance with regulatory labeling requirements for our pharmaceutical products.
Job DescriptionResponsibilities include 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.
This position requires a strong understanding of EU and/or US labeling regulations and guidance, as well as proficiency in working with electronic document management systems (e.g., Veeva).
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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