Regulatory Affairs Specialist
Vor 5 Tagen
CTC Resourcing Solutions supports companies in finding top talent and provides reliable HR, consulting services, and skill development programs. Our network helps candidates advance their careers and stay competitive.
Our client is a leading pharmaceutical company with a strong focus on novel therapies. 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 make key decisions regarding labeling documentation (CDS, BPL, BSS).
Main Tasks:- 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.
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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