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Senior Manager / Associate Director Regulatory Affairs CMC L

Company: Spectum Pharmaceuticals Inc.
Location: Irvine
Posted on: April 6, 2021

Job Description:

Senior Manager / Associate Director Regulatory Affairs CMC Large Molecules Tracking Code 732-470 Job Description Summary:This position will support global CMC regulatory activities related to investigational/commercial large molecule biologic products. This position will be responsible for preparation of global CMC regulatory submissions including authoring the module 3 sections to achieve timely approvals.Responsibilities:

  • Accountable for planning, authoring the content, and preparation of global regulatory eCTD CMC submissions and responses to Health Authority questions related to investigational and commercial biologics.
  • Identifies supporting documents required for global CMC submissions.
  • Authors and prepares CMC briefing documents for meetings with regulatory agencies.
  • Provides CMC regulatory support to project core teams.
  • Reviews CMC submission documents relative to regulatory guidance requirements.
  • Monitors, assesses, and maintains current awareness of evolving CMC regulations and guidance documents; apprises management of the impact of these changes.
  • Other activities as assigned.Required Skills, Education and Experience:
    • B.S./B.A. required in Chemistry or Life Sciences; advanced degree preferred.
    • Minimum of 7 years of related experience in biologics with strong module 3 writing experience.
    • Specific experience related to the preparation of global regulatory eCTD CMC submissions for investigational and commercial biologic products.
    • Demonstration of positive interaction skills and work ethic.
    • Proven communication skills (verbal and written).
    • Excellent organizational skills and attention to detail.
    • Capable of working independently and in a team environment.
    • Ability to manage multiple tasks simultaneously.
    • Ability to successfully negotiate in a team environment.
    • Excellent skills with MS Word, Excel, PowerPoint, and Document Management Systems.Availability:
      • Must be available to work in the evenings and weekends, as required.Position Location and/or Territory and Travel:
        • Position is in the United States (Irvine, CA or Cambridge, MA).
        • Position may require occasional travel.Spectrum Pharmaceuticals is an equal opportunity employer, we evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, and other protected characteristics. Job Location Irvine, CA or Cambridge, MA, United States Position Type Full-Time/Regular

Keywords: Spectum Pharmaceuticals Inc., Irvine , Senior Manager / Associate Director Regulatory Affairs CMC L, Executive , Irvine, California

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