Job Description
The Senior Regulatory Specialist is responsible for ensuring timely delivery of regulatory activities across multiple projects and dosage forms, meeting submission timelines and quality standards. Acting as the New Registration CMC representative on Regulatory Networks and Matrix Teams, the role provides regulatory guidance to Global Supply Chain (GSC), Commercial, Quality Assurance, 3rd Party Contract Management (via ESQ), and the Office of the Chief Medical Officer (OCMO) to enable preparation of appropriate components for global dossiers. The post-holder mentors and trains new team members to support their development and integration into regulatory workstreams. They also serve as a Subject Matter Expert for specific CMC/regulatory areas, offering consultation and expertise both within the department and to external stakeholders.
Key Responsibilities:
Independently develop and execute agreed dossier strategy to meet regulatory and business objectives.
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