Establish robust working relationships and processes with MC regulatory leaders, International iRAMs, iRADs, iCMC and cross-functional partners to reduce duplication and enable efficient hand-offs.
Ensure CoE teams prepare, compile, quality-check and deliver country-ready LCM packages, including Module 1 and administrative content, using approved international and CMC source materials.
Where applicable, lead the CoE labelling adaptation and implementation capability for assigned products, ensuring the team has the expertise, tools, templates and quality controls to deliver high-volume, multi-market labelling changes accurately and efficiently on behalf of MC teams....
Establish robust working relationships and processes with MC regulatory leaders, International iRAMs, iRADs, iCMC and cross-functional partners to reduce duplication and enable efficient hand-offs.
Ensure CoE teams prepare, compile, quality-check and deliver country-ready LCM packages, including Module 1 and administrative content, using approved international and CMC source materials.
Where applicable, lead the CoE labelling adaptation and implementation capability for assigned products, ensuring the team has the expertise, tools, templates and quality controls to deliver high-volume, multi-market labelling changes accurately and efficiently on behalf of MC teams....
· Own demand intake, prioritisation, work allocation, capacity visibility and delivery governance for LCM activities transferred from participating MC teams.
· Lead complex or high-impact dossier customisation and submission delivery, providing expert advice on country requirements, post-approval pathways, CMC change management and operational strategy.
· Establish robust working relationships and processes with MC regulatory leaders, International iRAMs, iRADs, iCMC and cross-functional partners to reduce duplication and enable efficient hand-offs....
Support Operations and the Supply Chain Security Manager by managing intake, triage and investigation of thefts reported within the region of responsibility
Works with key market stakeholders within the region to understand how illegal trade impacts the geography and to support prevention of illegal trade
Ensure that suspect sample testing is conducted on a timely basis, and liaise regularly with stakeholders across multiple functions including QA, Regulatory Affairs, Legal...
Support Operations and the Supply Chain Security Manager by managing intake, triage and investigation of thefts reported within the region of responsibility
Works with key market stakeholders within the region to understand how illegal trade impacts the geography and to support prevention of illegal trade
Ensure that suspect sample testing is conducted on a timely basis, and liaise regularly with stakeholders across multiple functions including QA, Regulatory Affairs, Legal...