Regulatory Operations Systems Administrator
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Job Summary
To support regulatory systems and submission management, the contract Regulatory Operations Systems Administrator will work remotely, focusing on Veeva RIM while partnering with various teams to ensure compliant and efficient regulatory operations.
Key responsibilities
- Serve as a business administrator for Veeva RIM, managing configuration, maintenance, and enhancements of regulatory systems
- Coordinate the preparation, tracking, and submission of regulatory applications and updates throughout the product lifecycle
- Collaborate with cross-functional teams to provide guidance on technical submission requirements and ensure compliance with global standards
Required qualifications
- Bachelor's degree in Life Sciences, Physical Sciences, or a related field
- 5+ years of Regulatory Operations experience in the pharmaceutical, biotechnology, or life sciences industry
- 3+ years of experience supporting regulatory submissions and managing regulatory systems
- Hands-on experience with Veeva Vault RIM and document management systems
- Experience with major global submissions, including INDs, NDAs, BLAs, and MAAs
Complete Job Description
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