
Global Labeling Operations Team Lead
12 hours ago
Sobi, a leading pharmaceutical company specializing in rare disease treatments and patient services, offers a unique opportunity for professionals to work on regulatory labeling operations.
Job OverviewThe Global Labeling Operations Lead will coordinate and manage activities related to printed labeling components, including packaging mock-ups and patient information leaflets. This role will also support the Global Labeling and Regulatory Strategy teams with operational labeling tasks and help develop internal processes.
This position falls under Global Regulatory Affairs (GRA) and reports to the Head of Global Labeling.
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.
- Coordinate EU labeling readability testing and translation activities with vendors and oversee affiliate review of EU SmPC translations during linguistic review.
- Manage EU SmPC master documents in Veeva RIM during product labeling life cycle.
- Collaborate with Global Strategic Labeling Leads to support delivery of submission-ready EU and US labeling documents.
- Serve as liaison to external vendor regarding creation, review, and submission of US Structured Product Labeling (SPL) content.
- Support global labeling management improvement initiatives and participate in development of SOPs, Work Instructions, and guidance 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.
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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