Valeant Pharmaceuticals International, Inc. is a diverse and decentralized pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.
The Regulatory Affairs – CMC Manager independently manages all regulatory CMC aspects of Valeant’s Pharmaceuticals products throughout their life-cycle with minimum supervision. This includes Brand, Generics, OTC/Nutritionals, Dietary Supplements and Medical Devices. The Senior Manager is responsible for the regulatory CMC strategy of all submissions and managing interactions with regulatory authorities on CMC issues.
Does not supervise any direct reports.
The Scope of the Position: Formulate, lead and drive CMC regulatory strategy with minimum supervision for development and marketed products. Lead and drive all CMC submission activities (planning, authoring, reviewing, coordination, submission). Support or manage with minimum supervision FDA or other Health Authority interactions on CMC issues.
Key Relationships: Internal business functions relating to developing regulatory CMC strategies, CMC submission activities and health authority interactions on CMC issues.
Valeant is an EEO/AA employer M/F/D/V.
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