Compliance

• Collaborate with cross-functional teams and a wide range of stakeholders from all over the world to deliver high-quality CMC dossiers.
• Play a key role in delivering regulatory submissions and ensuring compliance with evolving global standards.
• Identify risks associated with submission data and information packages.
• Independently manage multiple BioPharm project assignments simultaneously; assignments will range in complexity, but more complex work is expected.
• Communicate across GSK, as necessary regarding project and policy issues ensuring optimum position for GSK.
• Independently complete data assessment to ensure dossier is fit for purpose.
• May act as reviewer/approver for dossiers prepared by peers and identify improvement opportunities for Regulatory processes, policies and systems.

Senior Regulatory Specialist

Regulatory Manager