Senior Manager Core Labeling
Vor 4 Tagen
Career advancement requires continuous learning and professional growth. CTC Resourcing Solutions offers skill development programs to help professionals improve their skills and stay competitive.
Our client is a leading pharmaceutical company with a strong focus on innovation. They have a robust pipeline with multiple Phase II/III projects.
In this role, you will be responsible for developing and maintaining regulatory-compliant core labeling documents. You will lead the global labeling strategy and ensure global consistency in labeling implementation with Country Organizations.
Main Responsibilities:- 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.
- 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.
Qualifications:
- 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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