Regulatory

  • location: Lexington, MA
  • type: Contract
  • salary: $76.90 - $90.48 per hour
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job description

Regulatory

Manager, CMC Regulatory Submissions II

Job Responsibilities

  • This role will be dedicated to Servier support of submission activities until BLAs are transferred
  • Execution of global CMC Regulatory Submissions operational activities for Oncospar, Onyvide and Calpeg ongoing submission activities as per technical service agreement with Servier.
  • Initiate and facilitate kick-off meetings, coordinate and manage authoring of submission sections, review cycles, content verification.
  • Operational activities in electronic systems like EDMS (Baxedge), PleaseReview, Premier (MS Project) to enable submission preparation and finalization by the SMEs and reviewers/approvers
  • Justification;
  • Management and transfer of CMC submission documentation in EDMS to ensure all documentation is maintained until license transfer to Servier.
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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