The Regulatory Affairs – CMC Medical Devices Senior Manager independently manages all regulatory CMC post-approval aspects of Valeant’s Pharmaceuticals medical device products. This includes assessing manufacturing changes for regulatory impact, coordinating development of regulatory strategies for regulatory submissions in support of the manufacturing changes and authoring the necessary post approval submissions including annual reports and memoranda to technical files. The Senior Manager manages interactions with regulatory authorities on CMC issues.
Scope of Position:
Formulate, lead and drive post-approval CMC regulatory strategy for marketed products. Lead and drive all CMC submission activities (planning, authoring, reviewing, coordination, submission). Lead FDA or other Health Authority interactions on CMC issues.
Internal business functions including Manufacturing Site Operations, Quality, Supply Chain, Regulatory Product Leads.