Senior Regulatory Specialist – New Registration CMC

About the role

GSK is seeking a Senior Regulatory Specialist to lead New Registration CMC activities across multiple dosage forms. The role ensures timely delivery of regulatory components for global dossiers and provides mentorship to junior team members.

Key responsibilities

• Execute agreed dossier strategy independently and manage several projects simultaneously.
• Assess data to confirm dossier fitness and identify submission risks.
• Escalate business‑impacting issues to line manager.
• Review peer dossiers and suggest process improvements.
• Provide regulatory guidance to Global Supply Chain, Commercial, Quality Assurance and external partners.
• Act as subject‑matter expert and mentor for new staff.

Required profile

• Bachelor’s degree in Chemistry, Pharmacy or a related biological science.
• Strong English language proficiency.
• Solid understanding of drug development, manufacturing and supply processes.
• Knowledge of worldwide CMC post‑approval regulatory requirements.

Required skills

• Regulatory affairs
• CMC (Chemistry, Manufacturing & Controls)
• Drug development processes
• Manufacturing and supply chain knowledge
• Post‑approval regulatory requirements