Global Labeling Expert
vor 1 Tag
The Life Science Career Network is a platform that connects companies with top talent. CTC Resourcing Solutions specializes in providing reliable HR, consulting services, and skill development programs to support candidates in advancing their careers.
Our client is a global pharmaceutical leader headquartered in Basel, Switzerland. They focus on novel therapies in Oncology, Ophthalmology, Neuroscience, and Dermatology, with one of the world's strongest Phase II/III pipelines.
We are seeking an experienced and highly motivated Senior Global Labeling Manager for this contract position. This role involves developing and maintaining regulatory-compliant core labeling documents for assigned developmental programs and Novartis Innovative Medicines products.
Key Responsibilities:- Develop a global labeling strategy and make key decisions regarding labeling documentation (CDS, BPL, BSS).
- Present changes for approval and align stakeholders (GLC, ELTF, RA Sub-teams, SMTs).
- Research regulations, competitor labels, and clinical data to support updates.
- Ensure global consistency in labeling implementation with Country Organizations.
- Develop regulatory documents, respond to Health Authority queries, and support safety communications.
- Review and approve PSUR RA input and International Package Leaflets.
- Mentor junior labeling managers and drive process improvements.
- Provide expertise on regulatory trends and represent GL in audits.
Requirements:
- Education: Bachelor's or Master's degree in a science-related field (MD, PhD, PharmD preferred).
- Languages: Fluent in English; additional languages are a plus.
- Experience: 4–6 years in global labeling or 5+ years in regulatory affairs/pharma.
- Skills: Strong regulatory knowledge, project management, leadership, and problem-solving.
- Expertise: Medical terminology, drug safety, risk management, and business priorities.
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