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
- Management and transfer of CMC submission documentation in EDMS to ensure all documentation is maintained until license transfer to Servier.
- 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.