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Job

Senior Manager, Regulatory Affairs CMC

  • Location

    New Jersey

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Marissa Saunders

  • Contact email:

    m.saunders@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    2 months ago

  • Expiry date:

    2020-05-30

A Pharmaceutical client of ours focused in the oncology and neurology space is looking for a Senior Manager of Regulatory Affairs CMC individual to join their team in New Jersey. 

Description

The role functions will include both developmental projects and post approval projects

  • Will be responsible for agency communications and clinical development documents (INDs, IMPDs, and CTAs)
  • Prepare original MMAs, NDAs, and Growth Market dossiers
  • Develop regulatory strategy, interact with stake holders, and lead CMC authoring kick off meetings
  • Prepare CMC post approval supplements such as change supplements, annual reports, and product renewals
  • Track Module 3 leaf changes from submissions and post approval activity 

Requirements

  • Must have CTD dossier experience with modules 2.3 and 3
  • Bachelor's degree is required, scientific degree is preferred
  • Experience in CMC activities including management of development activities and post approval activities

This role is actively interviewing, so please apply now if interested and feel free to contact me at m.saunders@hamlynwilliams.com