The Associate Director, CMC Regulatory Affairs provides leadership for an assigned product portfolio with a focus on ex... experience, and at least 5 years of relevant CMC/device experience. You are willing and able to travel internationally...
with global PDS&T CMC teams to support development and supply strategies for new products Assist cross-functional teams locally...
with global PDS&T CMC teams to support development and supply strategies for new products Assist cross-functional teams locally...
Ideally experience in leading CMC studies including method validation Proven problem solving and troubleshooting abilities...
control strategies for products during Technology Transfer and commercial manufacture stages. Author, review and approve CMC... flexibilities built in to minimize impact of future process changes Serve as the empowered Operations representative on CMC Product...
and/or validation. Collaborate with CMC QA, R&D, S&T, clients and other functional groups to maintain roles and responsibilities...
and/or validation. Collaborate with CMC QA, R&D, S&T, clients and other functional groups to maintain roles and responsibilities...
. Experience supporting CMC regulatory submissions or authoring technical sections for regulatory documentation. Previous...
, Mechanical) related field is desirable. Experience of authoring CMC sections of regulatory submissions Previous leadership...
to project management and deal with client audits Ideally experience in leading CMC studies including method validation...