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Manager / Senior Manager, Regulatory Affairs CMC

Alkermes Waltham, Massachusetts
manager senior regulatory cmc cmc cancer commercial products schizophrenia regulatory strategy manager people mental
December 4, 2022
Alkermes
Waltham, Massachusetts
  • Alkermes is offering exciting opportunities through our commitment to work together to help improve the lives of people living with serious mental illness, addiction and cancer.
  • We are inspired by the courage and determination of individuals living with complicated and often difficult-to-treat diseases.
  • We have a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurological disorders and cancer.
  • Regulatory Affairs CMC supports a portfolio of small molecule and biologics development programs and commercial products across multiple locations and is committed to providing the best strategy every time through dedicated teamwork, professional excellence, and collaboration at every opportunity.
  • The Manager/Senior Manager of Regulatory Affairs CMC will support development CMC team activities for an emerging portfolio of small molecule programs in neuroscience.
  • This position will oversee CMC Health Authority submissions, collaborating across the business and with external partners to develop submission content and strategy.
  • This position is eligible for a hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office.
  • This role is not eligible for fully remote work.

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