
Labeling Artwork Lifecycle Manager
11 hours ago
Sobi is committed to delivering high-quality pharmaceutical products that meet the needs of patients with rare diseases.
Global Labeling Operations LeadAs a member of our Global Regulatory Affairs team, you will be responsible for coordinating and managing activities related to printed labeling components, including packaging mock-ups and patient information leaflets.
Key Responsibilities:
- Manage labeling artwork projects across multiple products to ensure timely delivery.
- Coordinate lifecycle management of labeling artwork with the Regulatory Strategy Leads and Labeling Operations Coordinators.
- Provide expertise to cross-functional teams and external vendors regarding regulatory requirements for printed labeling components.
- Review and approve mock-ups and artworks for compliance and timely delivery of print-ready packaging and labeling documents.
Education/Learning Experience/Work Experience
- Minimum 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 track record of leading projects and collaborating effectively in cross-functional teams.
Skills/Knowledge/Languages
- Strong knowledge of EU and/or US labeling regulations and guidance.
- Proficiency in working with electronic document management systems (e.g., Veeva), MS-Office Suite, and Adobe Acrobat.
- Fluency in English, additional language skills are beneficial.
- Ability to think strategically, communicate risks effectively, and recommend appropriate courses of action.
- Strong attention to detail and excellent communication and negotiation skills.
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