Senior Manager, Regulatory Operations
Job Summary
To support the development of life-changing treatments, the remote Senior Manager, Regulatory Operations will provide operational leadership for global regulatory submissions, manage Regulatory Information Management, and optimize regulatory processes while collaborating with cross-functional teams.
Key responsibilities:
- Provide operational leadership supporting global regulatory submissions from planning through archival
- Serve as the business lead for Regulatory Information Management and Veeva RIM Basics
- Partner with cross-functional stakeholders to implement standardized document lifecycle management
Required qualifications:
- Bachelor's degree in Life Sciences or related discipline, or equivalent combination of education and relevant Regulatory Operations experience
- Approximately 6-10 years of Regulatory Operations experience within the biotechnology or pharmaceutical industry
- Extensive experience supporting FDA electronic submissions
- Strong knowledge of eCTD publishing and submission lifecycle management
- Experience with Veeva Vault RIM or Veeva RIM Basics
Complete Job Description
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