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Develop and execute submission strategies for post-approval CMC activities, including variations and renewals for vaccines and biologicals. Coordinate with cross-functional departments to review study reports and ensure compliance with global regulatory requirements.
Develop and execute submission strategies for post-approval CMC activities, including variations and renewals for biologicals and vaccines. Coordinate with cross-functional departments to review study reports and ensure compliance with global regulatory requirements.
The role supports the global framework for identifying and managing third-party risks and fraud detection initiatives. It involves collaborating across various departments to embed compliance controls and monitoring transactions for unethical sourcing or conflicts of interest.
The Senior Consultant acts as the principal labeling strategist within Global Regulatory Affairs, driving the development and maintenance of key labeling documents like the CCDS, USPI, and EU SmPC for assigned products. This role ensures optimal alignment of company position, labeling requirements, and commercial opportunities while providing strategic input from a labeling perspective to the GRA Therapeutic Area Team.
The Regulatory Affairs Manager will act as the Lead RAM for assigned studies, managing regulatory aspects including the development of regulatory management plans and documentation submissions. They will also provide training to junior staff and serve as the primary contact for the Sponsor's regulatory group.
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